Regulatory Writing

Brief Introduction and Type of Documents

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Regulatory Writing

Regulatory writing is part of the clinical research which deals with the
documents meant for the submission to the Regulatory Authorities (like
USFDA, EMEA, TGA, Health Canada, ANVISA etc).

So, these are the documents required in the approval process for the
drug, devices, and biologics by the various Regulatory Authorities.

The entire process drives the demand for well-written, standardscompliant, clear, and concise documents that reviewers can easily read
and understand.

Latest developments, new and updated guidelines issued by regulatory

authorities are the core attributes of the regulatory writing.

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Requirement

Regulatory documents are submitted to track and evaluate the

ethical and procedural conduct of a trial and the quality of the
data that is produced during clinical trial.

Regulatory documents demonstrate the compliance of the

Investigator, Sponsor and Institutional Review Board
(IRB)/Independent Ethics committee (IEC) with the standards of
Good Clinical Practice.

Regulatory documents demonstrate the compliance with all

applicable regulatory requirements since inception (preclinical
phase) to development (Clinical phases from 1 to 4) of the drug
products.

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Regulatory Writer: Essential Qualities

Academically sound with a scientific or medical degree

Good liaising skills to involve with different working departments

like clinicians, statisticians, study management team,
investigators, pharmacokinetics/pharmacodynamics, regulatory,
safety etc.

Good understanding of drug development processes and

regulation, clinical trial designs

Clear understanding of the latest global regulatory requirements,

ICH and GCP

Good therapeutic area knowledge

Logical thinking and thorough research

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Regulatory Writer: Essential Qualities

(Contd.)

Must understand the data to interpret it correctly

Must have ability to summarize the statistical findings

Must have knowledge to work on structured templates, clear and

concise writing, different standard style guides

Good proof-reading ability and critical review of the developed

content for quality, grammar, punctuation, flow, compliance, and
style guide used

Must have strong editing and formatting capability

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Regulatory Documents
The various regulatory documents which needs to be submitted
to the Regulatory Authorities for product approval are given
below:

Investigational New Drug (IND)

Clinical Study Protocol

Informed Consent Forms

Case Report Forms

Clinical Study Reports (CSRs)

Investigators brochure (IB)

Safety Narratives

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Regulatory Documents (contd.)

Formulary dossiers

Periodic Safety Update Report (PSUR)

development safety update report (DSUR)

Common Technical Documents (CTD)

Risk Management Plan (RMP)

Risk Assessment Plan (RAP)

Summary of product characteristics (SmPC)

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Career Options and Benefits

The potential employers for the regulatory writers are:

Pharmaceutical/biotech companies

Different contract research organization (CRO)

Medical Communication agencies

The regulatory writers can also work as a Freelancer

The Key benefits are:

Different variety of projects with different therapeutic area

Home-based or remote working

Clear and progressive pathway

Good mentorship and training

Good financial benefits

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Benefits and Drawbacks of Freelancer

The key benefits are:

You are your own boss

Working flexibility with preferred time and work

Potential to earn more

The key drawbacks are:

Lack of continuous work

Losing the benefits of a permanent employment (Insurance,

pension, regular salary)

Limited sources of discussion/training which can be done inhouse

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Thank You

So, combine your passion for learning

about new science, new therapeutic
area and medicine with your
enjoyment of writing

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