The Digest of Biotech Job Trends

in Massachusetts

2017

Brief V: Regulatory Affairs

 Regulatory Affairs Brief MassBioEd

About the MassBioEd Foundation

MassBioEd engages teachers, inspires students, and guides the life sciences workforce. Our
BioTeach program supports Massachusetts teachers as they work to engage students
through lab-centered, inquiry-based learning. Our Job Trends initiative identifies
workforce needs and illuminates the pathway from the classroom to careers in the life
sciences.

About The Digest of Biotech Jobs Trends in Massachusetts

The Regulatory Affairs brief is a part of MassBioEd’s ongoing Digest of Biotech Jobs Trends
in Massachusetts, which also includes Quarterly Reports, One-off Briefs, a Medical Device
Snapshot, and an annual Job Trends Forecast. The Briefs present basic data and analysis on
particular aspects of biopharma industry job trends. The initial 2015 Briefs are focused
upon entry level position job trends in the biopharmaceutical industry.

The objectives in publishing the Briefs is to provide basic information about job listings
trends, skills required of candidates, prevalence of degree requirements for high trending
occupations. The Annual Job Trends Forecast is intended to provide greater insight based on
additional study in these areas.

Acknowledgements

The analysis found in the 3-Month Report was conducted by Mark Bruso, Manager of
Workforce Research, under the direction of MassBioEd Foundation Executive Director,
Peter Abair. Erica Dickinson, Product Support Manager at Burning Glass provided able
assistance to the MassBioEd research team in effectively using data from Burning Glass
Technologies. MassBio, the industry council serving the biopharmaceutical community of
the Massachusetts region, provided support for this series and MassBioEd’s ongoing job
trends initiative. Many thanks to Stephen Amato, Joni Beshansky, Lynn Squillace, Michael
Drues, Paul Beninger, and many others for their guidance on training and education within
the regulatory profession.

For more MassBioEd job trends analysis, visit MassBioEd.org.

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 Regulatory Affairs Brief MassBioEd

Introduction
Among the issues raised in our survey of industry professionals ahead of our annual Job
Trends Forecast in May 2016, the competition for experienced workers in the Regulatory
and Compliance space ranked among the most pressing. In the survey, which respondents
from companies representing nearly 10,000 workers in the state replied, 20 percent stated
that “regulatory,” along with “research” and “process/product development” were the most
difficult-to-fill. 78% responded that it is more difficult now, compared to three years ago, to
hire qualified talent, regardless of experience level or functional area. This, along with the
fact that over 93% of respondents in the same survey stated that job openings for
experienced workers were more difficult to fill than entry level, reveal that employers face
increased challenges in finding qualified candidates.

The goal of this Brief is to place a spotlight on these job areas of concern within the
industry, as they are the most likely areas to experience staffing problems in the near
future. Using labor market data gleaned using Burning Glass’ Labor Insight program, along
with input from industry professionals, we intend to present an overview of the current
state of the labor market in these job areas, highlight problematic areas, and present
current and proposed methods of alleviating the hiring pressures experienced today.

Executive Summary
The Regulatory Affairs field within the biopharma industry is a critical area for any
company developing products toward commercialization. Securing qualified workers for
the array of positions within the field is a central task for human resource departments in
biopharma companies.

This Brief has found that:

 As the biopharma industry in Massachusetts has grown and matured, with more
companies at later stages of product development, the need for professionals with
regulatory skills and experience has increased substantially,
 Between 2012 and 2015, job listings for regulatory affairs positions increased by
65% in Massachusetts,
 90% of professionals in regulatory affairs begin in positions outside of regulatory
affairs,
 Larger companies depend on developing talent for regulatory affairs positions from
within their company,
 Smaller companies externally recruit talent for initial regulatory affairs hires,

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 Regulatory Affairs Brief MassBioEd

 The competition for more senior level regulatory professionals places a strain on
hiring, especially for smaller companies, which can result in a slower pace for
regulatory submissions and product development,
 Training within companies for regulatory positions is largely driven by the product
centric focus of particular companies, making the development of pertinent external
training problematic,
 A limited number of universities offer programming in regulatory affairs, but at the
graduate or graduate certificate level only,
 Graduate programs in regulatory affairs are seen as skill enhancements to advance
incumbent regulatory affairs professionals, rather than preparatory programs for
new entries to the regulatory field,
 Greater availability of educational programs introducing experienced non-
regulatory workers to concepts fundamental to the regulatory field would enable
companies to externalize basic training for workers they are developing for
regulatory positions.

Regulatory Affairs Overview

Unique in its training and selection of workers, Regulatory Affairs departments face a
difficult time sourcing qualified talent. Consistent with anecdotal evidence, labor market
data reveals a dearth of entry-level openings in regulatory affairs or compliance positions.
This is due to the nature of work done in the space. Regulatory Affairs professionals are
tasked with an important role within the overall structure of commercializing a therapy.
They are the conduit between the research and product development occurring in labs
with the rules and regulations governing them set forth by the Food and Drug
Administration (FDA). As the outward-facing department they play a critical role - ensuring
that submissions and reporting are done in a timely and clear manner - so that potentially
life-saving therapies are completed and marketed on schedule and in a cost-effective way.

Explaining Roles in Regulatory Affairs

While Regulatory and Compliance duties often overlap and are conflated, it is crucial to
first make a distinction between their essential functions. In their basic element,
Regulatory professionals are responsible for reporting to regulatory agencies,
communicating that activities taking place within their companies are within the bounds of
rules and regulations set forth by the FDA. Oftentimes, this means they communicate to
regulatory agencies regarding the technologies and techniques used and therapies being
developed within their organizations. Compliance professionals are more concerned with
accountability, meaning they are much more inward-facing, making sure that all activities
completed by their employees are in strict accordance with the rules and regulations in

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 Regulatory Affairs Brief MassBioEd

place. It is easy to see why these roles are often grouped together, as they perform
intersecting functions.

For the purpose of this report, we seek to look at all occupations within biopharma whose
main duties place them either in a regulatory or compliance role, henceforth considered
“Regulatory Affairs.” Regulatory Affairs Specialists, Compliance Officers, Compliance
Managers, and Documentation Control Specialists are all occupations whose core duties are
devoted to regulatory functions at biopharma companies. A number of Technical Writers
find themselves in these roles. Not wanting to limit our scope to obvious occupations, we
scoured real-time labor market data to get a sense of other occupations in which a
contribution to regulatory or compliance activities is central to their position1. By doing
this, we believe we have isolated occupations outside the main basket of occupations that
are devoted to regulatory-related work. Some job openings tagged as Administration
Manager, Medical Director, and Project Manager were in actuality, regulatory positions.
This helps us in defining the space that is otherwise nebulous in structure.

Scope of Practice and Time Allocation

Every two years the Regulatory Affairs Professional Society, or RAPS, conducts a
worldwide survey of regulatory professionals within healthcare-related industries, such as
Pharmaceuticals and Medical Devices. The biannual report is titled Scope of Practice and
Compensation Report for the Regulatory Profession and is available for free download on
raps.org and contains a trove of pertinent data on the state of the regulatory profession.

The 2016 edition collected responses from 3,358 individuals in the profession,
approximately 2,500 of which originated from within the United States. The survey
provides a comprehensive overview of the profession, looking at educational and
professional backgrounds, compensation, work setting, time allocation, and job duties.

Survey respondents were asked to classify themselves into any professional class within
Regulatory Affairs. The most common self-selected job levels were Manager (24%),
Specialist (24%), Director (19%), Associate (8%) and Vice President (5%). A rough
hierarchy begins at Specialist and Associate, which are approximately equivalent in
earnings and duties, to Manager, Director, and finally Vice President. Using these self-

1
Using Burning Glass Technologies’ Labor Insight tool, we simply examined all job listings thus far in 2016 with the
keywords “regulatory” or “compliance” within their title, in occupational fields not listed above, in lieu of a keyword
search, which would have returned numerous false-positives (i.e. regulatory or compliance is mentioned in the duties of a
job listing, but it is not the focal point of the job).

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 Regulatory Affairs Brief MassBioEd

assigned job levels, we can tease out differences in wages, duties, time allocation, and work
experience between the four main groups.

Time use was divvied up into five broad categories: business-related, regulatory strategy,
preapproval/approval, post-approval, and training/education. Furthermore, each job level
time allocation was dissected by workplace setting, which showed “no significant
variations by region.” What follows are the differences in time allocation by job level within
the industry in 2016.

Specialist/Associate* Manager Director Vice President

2012 2014 2016 2012 2014 2016 2012 2014 2016 2012 2014 2016
Business-
13% 11% 12% 22% 17% 19% 27% 23% 22% -- 33% 31%
Related
Strategy,
Intel, & 17% 15% 37% 13% 19% 34% 18% 21% 35% -- 14% 27%
Ops
Pre-
39% 41% 23% 31% 34% 22% 27% 29% 20% -- 28% 20%
Approval
Post-
32% 35% 22% 29% 27% 22% 24% 24% 21% -- 23% 20%
Approval
Training
-- 3% 3% -- 3% 3% -- 3% 3% -- 2% 2%
/Ed.
*Specialist and Associate were combined by averaging the ratios from both job levels, may not equal 100%

The sole divergence this past year in time allocation occurs between Specialist/Associates
and Vice Presidents, where the former spends far more time in regulatory strategy in lieu
of business-related projects.

Major shifts in time allocation have occurred since 2012. Across-the-board increases in
emphasis on the regulatory strategy category occurred simultaneous to a drop in time
allotted to pre-approval activities, with much of the drop-off appearing between 2014 and
2016. This re-ordering of priorities may be due, in part, to “a more strategic approach to
the work undertaken by regulatory staff and a greater integration of regulatory strategy,
intelligence and operations into regulatory lifecycle management.i”

Hiring Trends
Limited Entry Level Positions in Regulatory Affairs

As noted above, hiring managers in the industry have listed regulatory positions among the
most difficult to fill. Unlike many other functional areas, such as Research or Quality, there
isn’t a direct pipeline from higher education into regulatory roles within the industry.

Typically, companies that do not contract out their regulatory duties to outside firms

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 Regulatory Affairs Brief MassBioEd

Entry Level Share of 2013 2014 2015 2016

Regulatory/Compliance Openings 16.2% 12.4% 12.1% 8.5%
are forced to either develop workers from within their organization – often sourcing them
from other departments – or they must hire away experienced workers from other
companies in the industry. This problem exists because regulatory positions require basic
regulatory environment knowledge, a scientific research background, incredible attention-
to-detail, or some combination of the three. That makes finding and hiring inexperienced
workers difficult. The industry-wide rate of openings for those with 0 – 2 years’ experience
(entry level) at 25%, yet for positions in regulatory/compliance it is 10%. In the first half of
2016 it was at the
Entry Level Share of Job Listings, By Occupation lowest rate since 2013,
at 8.5% (see above).
Occupation 2013 2014 2015 2016
Regulatory Affairs Specialist 27% 18% 20% 23% The industry appears to
Compliance Officers 26% 29% 25% 0% be in the midst of
Compliance Manager 3% 1% 0% 0%
experience inflation in
Documentation Control
54% 38% 26% 19% these positions,
Manager/Specialist
Technical Writer 31% 7% 7% 11% wherein entry level
Miscellaneous Positions 10% 11% 13% 10% share of openings has
been halved in only 3
years. The decline has been concentrated in Compliance Officer, Technical Writer, and
Document Control Manager/Specialist positions. The decrease in the entry level share of job
listings between 2013 and 2016 for Technical Writers was 20 percentage points, for
Document Control Specialists it was 35 percentage points.

The number of openings available to those lacking at least a four-year degree is low.
Excluding Document Control Specialists from the aggregate, approximately 1-2% of
openings allow for
applicants to possess Occupation Assoc. Bach. Grad
less than a bachelor’s Regulatory Affairs Specialist 0% 91% 9%
degree. For Document Compliance Officers 0% 96% 4%
Control Specialists, Compliance Manager 2% 81% 17%
however, 4-in-10 Documentation Control
42% 58% 0%
listings required less Manager/Specialist
Technical Writer 3% 93% 5%
than a bachelor’s
Miscellaneous Positions 2% 81% 17%
degree. Generally
speaking, the data reinforces the commonly held notion that entry level opportunities in
these occupations are difficult to come by.

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 Regulatory Affairs Brief MassBioEd

Expanded Need for Experienced Regulatory Professionals

Historically, Regulatory Affairs professionals were only necessary once a company had a
therapy in the clinical stages of development. But over the course of decades, the
regulatory environment has evolved to the point where those same professionals are
employed by companies at all phases along the discovery pipeline. As the size of research
Employment Growth, operations in the state has grown by approximately 30% in
Regulatory Affairs the past decade – from 24,565 employees in 2007 to 31,469 in
positions, 2012-15 2015 – the need for Regulatory Affairs professionals has
65% expanded as well. From 2012 to 2015, the number of
Regulatory Affairs Specialists and Compliance Officers (non-
management) employed by biopharma firms in the state has grown from 624 to 1,027 –a
compound annual growth rate of over 18% resulting in total growth over the three year
period of 65%. Curiously, over the same period in question the inflation-adjusted annual
median salary for those workers decreased slightly, from about $84,500 in 2012 to just
under $84,100 in 2015 – a decrease of 0.4%.

Standard economic models state that if demand for workers increases, as it has for those
two occupations since 2012, that a corresponding wage increase will occur if the supply of
workers does not keep pace. Even as employment in Regulatory Affairs Specialist and
Compliance Officer positions increased by almost two-thirds in the span of just three years,
companies did not have to raise
wages to attract workers. On the 2012 2013 2014 2015
$140,000
contrary, real wages declined by $120,000
0.4%. Wages at the lower end of $100,000
the spectrum – the 10th and 25th $80,000
percentiles – each witnessed an $60,000

even more marked decline in $40,000

$20,000
relation to median pay. From 2012
$-
through 2015, wages for workers 10th 25th 50th 75th 90th
at the 10th percentile saw a 7.6% Percentile Percentile Percentile Percentile Percentile

decline in their real wages and

those at the 25th percentile dropped 6.6%. The base year of 2012 had an unusually high
salary at the 90th percentile, but when using 2013 as the base year in place of 2012, both
the 75th and 90th percentile wage growth was 3.9% and 3.1%, respectively, as the decline in
real wages at the 10th and 25th percentile was -4.8% and 3.1%.

This confirms the input received from our industry partners, gathered through our Skills
Advisory Group, which emphasized that finding willing workers for lower-level regulatory
affairs positions is not the concern – the problem presents itself when seeking to fill
positions with highly experienced workers. Larger companies are able to hire from quality

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 Regulatory Affairs Brief MassBioEd

assurance, validation, clinical research, and drug development roles which operate within
the bounds of the regulatory environment. Companies that are seeking experienced
regulatory professionals – namely smaller companies looking to grow their nascent
regulatory apparatus – cannot look in-house. Since they must look towards other
companies with established regulatory affairs professionals they must pay a wage
premium in order to secure their services, thus driving up pay growth at the upper ends of
the wage distribution.

In management roles, i.e. Compliance Managers, the real (adjusted for inflation) growth in
pay between 2012 and 2015 was 27%, growing at a rate of over 8% per annum. These
workers experienced growth in compensation like their
Employment experienced counterparts in Regulatory Affairs Specialist and
Growth, Compliance Compliance Officer positions. Employment totals within the
Managers, 2012-15
occupational group in which Compliance Managers reside – the
111% SOC code Managers, All Other, grew 111% from 116 workers in
2012 to 245 workers in 2015. Compliance Managers, Regulatory
Affairs Specialists, and Compliance Officers were all forecasted to grow 6.5% by 2018 within
the biopharma industry; this far exceeded the rate of growth projected for these
occupations by the state for all industries through 2022, which stood at approximately 3%.

Isolating these three key regulatory/compliance positions from the rest of the regulatory
sphere reveals a noteworthy trend. Since 2013, the percentage of total postings for
candidates with 0 – 2 years’ experience – “entry level” – shrunk every year. In 2013, 15%
were available to entry level workers, in the ensuing three years it declined to 12%, 10%,
and to 6% in the first half of 2016. This is a shade below the experience requirements for
all regulatory positions. This is partly driven by what we know about where companies
look for entry-level talent – within – which may have the effect of obscuring how many
entry level openings there are as companies do not post them externally. In turn, it is easy
to see why experienced openings dominate job boards – when companies look to fill those
positions they have no choice but to look at workers from outside the company.

In-Demand Skills
Each of the occupational groups within the regulatory/compliance sphere exhibits their
own unique skill profiles. Below are the top ten in-demand technical skills by occupational
group in the past 12 months.

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 Regulatory Affairs Brief MassBioEd

Pct. of All Pct. of All

Regulatory Affairs Specialists Compliance Officers
Postings Postings
Good Manufacturing Practices
Microsoft Excel 20% 56%
(GMP)
Technical Writing / Editing 11% Technical Writing / Editing 26%
Integrated Development
11% Microsoft Excel 21%
Environment (IDE)
Project Management 11% Project Management 20%
Good Manufacturing Practices
9% Internal Auditing 20%
(GMP)
Adobe Acrobat 8% Policy Implementation 19%
Good Clinical Practices (GCP) 7% Data Analysis 8%
Biostatistics 6% Good Clinical Practices (GCP) 7%
Failure Modes and Effects
Validation 5% 6%
Analysis (FMEA)
Data Analysis 5% Risk Assessment 5%

Pct. of All Pct. of All

Compliance Managers Document Control Specialist
Postings Postings
Good Manufacturing Practices
Project Management 27% 51%
(GMP)
Budgeting 21% Validation 31%
Labeling 16% Microsoft Excel 19%
Due Diligence 13% Root Cause Analysis 13%
High Performance Liquid
Microsoft Excel 11% 13%
Chromatography
Good Manufacturing Practices
9% Root Cause Analysis 13%
(GMP)
External Auditing 6% Ion Exchange 11%
Validation 6% Gel Electrophoresis 11%
Good Clinical Practices (GCP) 5% Crystal Reports 9%
Document Management 5% Technical Writing / Editing 8%

Pct. of All Pct. of All

Technical Writers Miscellaneous
Postings Postings
Document Management 34% Project Management 21%
Technical Writing / Editing 32% Microsoft Excel 12%
Data Management 21% Due Diligence 9%
Good Manufacturing Practices Good Manufacturing Practices
20% 9%
(GMP) (GMP)
Cell Culturing 15% Good Clinical Practices (GCP) 8%
Protein Purification 15% Negotiation Skills 8%
Process Improvement 14% Lifecycle Management 5%
Microsoft Excel 14% Good Laboratory Practices (GLP) 4%
Calibration 14% Adobe Acrobat 3%
Contract Preparation 13% Microsoft Sharepoint 3%

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 Regulatory Affairs Brief MassBioEd

In Technical Writers, a relatively high concentration of in-demand skills signifies that open
positions within that occupation group are much more similar to each other than open
positions within other groups, meaning there is likely little variation throughout the
industry in what duties and tasks are requested of these workers. The opposite is so for the
grouping of miscellaneous positions.

The most requested baseline skills - broad groupings of underlying and foundational soft
skills - among biotech-related regulatory positions
Top Baseline Skills – Regulatory
in the past 12 months are shown at right. All of Positions, Past 12 Months
these soft skills were in far more demand in these Communication 58%
positions when compared with all statewide Writing 50%
positions during the same period of time – Writing Research 33%
and Research were more than twice as common, Collaboration 29%
while the other skills ranged from 28% more Organizational Skills 26%
concentrated (Problem Solving) to 80% more Detail-Oriented 24%
Planning 23%
(Detail-Oriented).

Disparities between Small and Large Companies

As discussed in previous sections, the experiences of smaller companies are contrasted
with that of intermediate and large companies in the hiring, training, and development of
regulatory professionals. While the data shows both large and small companies post entry
level job listings at the same rate, it likely isn’t an accurate representation of the hiring
practices seen on the ground, as
large companies hire internally
and thus have less need to
search for talent on the outside.
As shown at left, the perceived
changes in regulatory
submission timelines for large
and small companies has shown
a divergence in recent years, as
small companies report longer
timelines (69%), while large
companies experience the
inverse – shorter submission
timelines (46%)ii.

Above - Cutting Edge Information: “Regulatory Affairs Talent Gap is a Problem for Small Pharma”

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 Regulatory Affairs Brief MassBioEd

This fact makes plain the struggles small companies face in ramping up regulatory
functions – many times they lack the infrastructure, specialized knowledge, or networks
required to take advantage of the expedition of submissions made possible by new FDA
rules and regulations. While smaller departments mean that regulatory professionals at
smaller-to-midsize companies are responsible for a wide swath of duties (operations,
strategy, etc.) and are by necessity more nimble, it does not result in faster submissions.

Particular to the biopharma industry is the duration of time it takes to fill a vacant position.
According to Randstad, the industry standard for filling any open position in 2016 was 105
days, or approximately 3 ½ monthsiii. This stands in great
Time To Fill Open contrast to the economy-wide lag between a job opening and a
Positions worker accepting an offer, which in September 2016 was 28
Biopharma All days, or approximately one monthiv. While the differences
105 days 28 days between large and small biopharma firms is not known at this
time, at the macro level smaller firms are able to fill vacant positions at a much quicker rate
than larger ones, reflecting in part a greater relative opportunity cost in letting a position
sit unfilled for a long time – which some estimate as a loss of $500 for every day a position
is unfilledv. Therefore small companies have a clear incentive to fill any position, and
regulatory positions specifically, as soon as they become available or necessary.

Pathways into the Regulatory Space

Developing From Within

Once again, the 2016 Scope of Practice and Compensation Report for the Regulatory
Profession gives us a good idea of the prior experiences of regulatory professionals – both
in terms of where they worked and how long they worked there before entering the
profession.

Anecdotally, only large companies with therapies in multiple stages of development are
typically able to hire entry/associate level Regulatory Affairs or Compliance Specialists from
within. According to the 2016 Scope, approximately 90% of all regulatory professionals got
their start in other functional areas. The table below identifies the top areas from which

Research Manuf./ Clinical Lab Pharmacy/ Clinical

Engineering
& Dev. Quality Research Sciences Pharmacology Professions
24% 22% 5% 5% 5% 5% 3%
regulatory professionals worked before transitioning. One shortcoming with this data,
however, is that it includes survey responses from regulatory professionals in all industries
– pharmaceuticals, medical devices, food, cosmetics, etc. – so that it is hard to tease out the
true sources of talent for biopharma companies. The same report found that respondents

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typically had 5-8 years of non-regulatory experience on their resumes 5-8 Years
before transferring into regulatory affairs. This confirms the widely held Experience
belief that entry into the profession remains difficult, and that most – if not Prior to 1st
Regulatory
all – regulatory professionals must build up years of related experiences
Position
before they are able to be considered for hire.

Back in 2011, RAPS reported the “feeder” areas for biopharma regulatory positions in
comaprison to medical devices and found that biopharma finds their new talent from R&D
and Clinical Research at similar rates, Quality and Engineering much less, and
Pharmacology and Drug Development at a much higher rate.

In hiring workers away from functional areas that may interface with regulatory on a
consistent basis, firms must train and develop these workers internally, as there are no
current academic programs at the undergraduate level that provide a breadth of regulatory
preparatory training for students or incumbent workers. Smaller-sized companies are
more apt to look towards outsourcing regulatory work to a third-party firm like a
contractor, CRO, or Contingent Resource Provider that can flexibly respond to ebbs and
flows in workload, e.g. submissions and filingsvi. These third-party firms provide a way for
inexperienced recent graduates from graduate programs in regulatory affairs to gain entry
into the profession on a non-permanent, contingent basis.

The key takeaway is that the dynamics of hiring large v. small firm is that this muddles the
pathways picture, as one would anticipate large disparities between the rates of entry level
openings at small- and large-sized companies. Two other core occupations – Document
Control Specialists and Technical Writers – seem to be islands unto themselves wherein
positions within that occupational group tend to be promoted within the occupational
group (i.e. a Document Specialist becomes a Document Specialist Lead). It becomes clear
that of the remaining core regulatory/compliance occupations that Regulatory Affairs
Specialists and Compliance Officer/Analysts are the gateway into the profession, each with
about one-fourth of their openings at the entry level since 2013 – level with the industry-
wide rate. Job titles ending with Specialist, Associate, and Officer come up frequently when
looking at this segment of job listings, eventually leading to job titles with Senior, Manager,
and Director affixed to it.

The following is an illustration of the hierarchy of titles within the regulatory space. It is
derived both from historical and real-time job market data, and is colored by commentary
gleaned for our industry insiders that reside on our Skills Advisory Group. Excluded from
this group are Technical Writers, which typically have I, II, etc. affixed to the end of their
title to signify the level of experience and responsibilities of the individual in the position.
The titles come from real job listings posted online in the past two years, and while this
should not be construed as the case at every company, it is a very close approximation of

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the pathway into higher-level positions within regulatory and compliance departments at
biotechnology and pharmaceutical companies in the Commonwealth.

Pictured Above: Hierarchy of Job Titles within Regulatory Affairs

Regulatory Affairs Educational Landscape

Just over a decade ago there were just a handful of academic programs in the United States
solely dedicated to Regulatory Affairs. In Massachusetts, there are now three separate
institutions of higher learning that are offering graduate-level training in regulatory affairs
– Regis College, Northeastern University, and Massachusetts College of Pharmacy and
Health Sciences (MCPHS).

Nationwide, about 10-12% of regulatory professionals began their professional careers

within regulatory affairs, representing a significant increase over a half-decade earlier
when approximately 2% began within the fieldvii. Combined with 65% growth in
employment numbers in core regulatory affairs positions in Massachusetts between 2012
and 2015, candidates coming out of these programs are in ever-increasing demand. The
decrease in wages at the bottom of the wage distribution in regulatory affairs, despite a

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65% increase in employment totals, signifies that the recent influx of graduates of these
programs is meeting the needs for eligible workers to fill these open positions.

Experience and Applied Learning seen as a Key

Generally, there are two tracks available – a full Master’s degree or a Graduate Certificate.
The Master’s programs are anywhere from 30 credits (10 courses) in length to 45 – taking
between two to three years to complete. In conversations with academics within these
programs, the importance of practical experience was highlighted. These come in the form
of practicums, case studies, internships/co-ops, etc. The academic programs are informed
of the need of these hands-on learning experiences through connections with industry, as
many programs are staffed with adjunct faculty members who simultaneously work full-
time in area biotech or pharmaceutical companies. Companies are reluctant to fill entry-
level positions within regulatory with candidates lacking industry experience, which
presents a catch-22 for workers outside the industry looking to gain entry into regulatory
roles.

Experiential learning, such as internships, were not required in any of the programs
surveyed, due in large part to the student body demographics – many were working
professionals unable to make the requisite time commitment. Representatives from the
academic programs in Massachusetts emphasized the availability of experiential learning
for those with the time and ability to complete them.

MCPHS Regis College

Master of Science, Drug Regulatory Master of Science, Regulatory and Clinical
Affairs and Health Policy Research Management
Graduate Certificate, Regulatory Management
Graduate Certificate, Clinical Research
Management
Northeastern University
Master of Science, Regulatory Affairs Graduate Certificate, Biopharmaceutical
for Drugs, Biologics, and Medical Devices International Regulatory Affairs
Master of Science, Biotechnology Graduate Certificate, Biopharmaceutical
Domestic Regulatory Affairs
Graduate Certificate, Medical Devices
Regulatory Affairs
Source: Regulatory Affairs Professional Society (RAPS.org)

This enhanced emphasis placed upon pedagogy involving applied learning in lieu of a
textbook-centered approach reflects the very nature of the regulatory field. While it is
relatively straightforward to look up FDA regulations, it is another to apply and adapt the
knowledge to real-life examples, or to be embedded within a company as it develops and

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employs regulatory strategy to its development pipeline. The unified concern with
providing students with these experiences shapes the regulatory educational landscape
within the Commonwealth.

More accelerated academic programs are available as well. All three schools offered
certificate tracks that students complete in approximately one-fourth of the time of the
Master’s programs. Incumbent workers see these programs as a vehicle for promotion, as
opposed to a program needed to gain entry into the profession. The certificate programs at
both Northeastern and Regis require the completion of four courses – three core classes
plus one elective at Regis, and two core classes and two electives at Northeastern.

Modularized programming provided by RAPS is another avenue for incumbent workers to

customize their professional development concurrently with working full-time. Unlike
certificate programs, which can be taken wholly in-person and on-campus, the RAPs
courses are offered online-only. The Regulatory Affairs Certificate in Pharmaceuticals is
composed of nine courses completed over a six month interval. Like certificate programs at
Regis and Northeastern, it requires a sequence of fundamental and overview classes to be
taken (4), followed by five elective courses allowing for a personalized area of focus.

Problem Areas and Potential Solutions

The intention of this report is to provide an overview of the current state of affairs within
the regulatory sphere in the biopharma industry in Massachusetts. Drawing from labor
market information, insights from industry professionals, and research from third parties
like RAPS & others are means by which we attempt to first quantify changes, and then color
the data with explanations from insiders.

There is no shortage of workers within the industry willing to transition into junior-level
regulatory affairs roles. But owing to its unique responsibilities, knowledge base, and
integral function along the pathway to commercialization of therapies, distinctive hurdles
obstruct the development of regulatory professionals. The onboarding of new hires in the
regulatory sphere takes a considerable amount of time before they are able to effectively
manage their job’s responsibilities. Effective training can take anywhere from six to twelve
months, with a considerable tail – meaning workers must continually learn on the job to
adapt to changes in regulations or to learn the numerous nuances of the job. Making this all
the more difficult is the fact that there is hardly any uniformity in regulatory positions –
there are not insignificant differences in tasks and duties depending on the therapeutic
area, stage, or countries/markets a company is doing business in. This, in turn, makes it
difficult, through an industry-academic collaboration to streamline training, education, and
professional development.

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 Regulatory Affairs Brief MassBioEd

A large influx in graduate-level educated workers in regulatory affairs programs in the past
decade has presented a nascent issue – an increase in job candidates with educational
qualifications simultaneous to a decrease in job postings for entry level regulatory affairs
openings. While there has been an increase of those entering straight into regulatory affairs
from outside the industry – most likely graduates of regulatory affairs academic programs -
in the past half-decade, there is still room for the industry and academia to raise the
marketability of recent graduates for junior-level regulatory affairs openings.

Larger companies will continue to develop talent in non-regulatory areas for regulatory
positions. The availability for additional external training resources for these candidates,
introducing fundamental concepts across the regulatory environment, should be helpful
transitioning incumbent workers into new roles in regulatory affairs

Companies and their employees in regulatory positions should explore existing graduate
programs as valuable opportunities to enhance and refine regulatory skills toward
attaining higher levels or responsibilities and performance.

The availability of training for particular, stackable skills (as seen on Page 8, above), such
as technical writing, GMP, GCP, GLP, and FMEA, can be expanded by introducing more of
these training program areas to the state’s Workforce Training Express program, which is
easily navigable and accessible to employers looking to enhance the skills of employees in
early- to mid-transition into regulatory roles.

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 Regulatory Affairs Brief MassBioEd

Appendix
MassBioEd utilizes Burning Glass Labor Insight for the bulk of its real-time online job
listing data. Per the description on Burning Glass’ website, their Labor Insight software,
“collects millions of online job postings [everyday] from close to 40,000 sources and
applies [their] patented technology to mine and code detailed data from each posting
describing the specific skills, education, experience, and work activities required for the job
– going well beyond the occupation and industry codes offered in other sources.”

All job listings data is sourced from Burning Glass Labor Insight, unless otherwise noted.

Employment numbers were derived from the Department of Labor, Bureau of Labor
Statistics’ Quarterly Census of Employment and Wages (QCEW), a survey of employers that
covers 98 percent of all workers in the country.

Staffing patterns, or the count of individual occupations by industry in the state, were
found by using Department of Labor, Bureau of Labor Statistics’ Occupation Employment
Statistics (OES) Research Estimates. These are derived from sample surveys and thus are
approximations subject to sampling error, as well as non-sampling errors by respondents
filling out the surveys.

The Regulatory Affairs Professional Society (raps.org) was an invaluable resource for scope
of practice data, and a range of other workplace trends within regulatory affairs. Data
regarding time allocation, previous employment, education, etc. were sourced from their
website and reports.

i
RAPS SoP 2016, pg. 7, http://stage.raps.org/twoColDetail.aspx?id=10555
ii
Cutting Edge Information, https://www.cuttingedgeinfo.com/2012/regulatory-affairs-talent-gap-is-a-problem-
for-small-pharma/
iii
Randstad Life Sciences/Pharma Workplace Trends Guide,
https://www.randstadusa.com/workforce360/recruitment-retention/life-sciences/
iv
Nov 2016 DHI-Hiring Indicators Charts, http://dhihiringindicators.com/
v
CEB and National Mean Vacancy Report (via Randstad)
vi
Thayer J, Falchuk J. “Transforming Temporary Resourcing into Strategic Resourcing.” Regulatory Focus. March
2014. Regulatory Affairs Professionals Society. Page 2
vii
SoP 2016

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