CURRICULUM VITAE

SOWMYA VALLABHAPURAPU Contact No:8088604207, 9493447232

Flat.no: Walnut-616 sowmyavallabhapurapu95@gmail.com
Rain Tree Park
Nagarjuna Nagar
Nambur, Guntur, AP-522508

Summary:

 Working as a highly motivated regulatory affairs Executive with one year experience for
regulatory markets like US, Europe, Canada, UK, Australia and RoW Markets.
 Experienced (two years five months) as a Formulation Scientist for offering outstanding
product development skill of Oral Solid Dosage forms like Tablets and Capsules.
 3 years 5 months of experience in Pharmaceutical Industry for product development,
technical operation, and manufacturing for Domestic & Regulatory Market.
 Keen Learner, Good team player, Ability to work under stressful situations.

Professional Experience:
 Executive, Regulatory Affairs
Axxelent Pharma Science Limited
IIT Madras Research Park, Taramani
Chennai, Tamil Nadu
March 2022 to Till Date

 Officer, Formulation development

Arizest Pharma (India) Pvt Ltd
Bangalore, Karnataka
December-2018 to April-2021

Job Profile:

Job Responsibilities (Regulatory Affairs) as an Executive:

 Preparing and filing the controlled correspondence to the regulatory agencies like USFDA,
Health Canada, EMA, UKMHRA and Australia.
 Ensured compliance with regulations set by the USFDA, Health Canada, EMA, UKMHRA and
Australia.
  Provide the inputs and regulatory expertise to the management on molecule manufacturing
feasibility for new products.
 Good knowledge on CTD and ACTD preparation.
 Reviewing and finalizing Certificate of Analysis (COA) for Active Pharmaceutical Ingredients
(API) compliance with appropriate market requirements.
 Reviewing the Product Development Plan (PDP) and Product development Report (PDR) as per
current guidelines and regulatory requirements.
 Checking the New generic approvals for USFDA, Health Canada, EMA, UKMHRA.
 Review and finalizing the Justification of Specification for Finished product and Raw material
specification (API) by meeting regulatory requirements.
 Reviewing the Nitrosamine impurities, Residual solvents, Geno toxic impurities and their Risk
Assessment.
 Review and compilation of DMF and CEP details.
 Checking and maintain the GMP compliance for COA sources like EIR, Eudra GMP, Health
Canada GMP and UKGMP.
 Preparing and Applying the Test License (Form 29) to State Licensing Authority (SLA).
 Preparing the documents and applying NOC (Form CT – 10/11 & Form CT 12/14), RLD Import
license (Form CT- 12/16) and API import license (Form CT – 12/16) to Central Drugs Standard
Control Organization (CDSCO).
 Resolving the queries received from the State Licensing Authority (SLA) and Central Drugs
Standard Control Organization (CDSCO).
 Coordinating and resolving any queries to the cross functional team regarding regulatory points.
Achievement’s:
 Received 4 approvals from USFDA and 1 from Health Canada on controlled correspondence.
 CDSCO and DDC/SLA GMP inspection clearance.
 3 Approvals for unapproved molecules received from CDSCO.
 More than 150 product approvals received from CDSCO and SLA.

Job Responsibilities (Formulation and Development) as an Officer:

 Development of products for Regulatory & ROW markets.

 Resolve the issues during product development.
 Execution of Lab trials, Drug –Excipient compatibility studies & Pre-formulation.
  Analytical data compilation and discussion.
 Responsible for initiation to completion of all the activities for assigned projects
with respective timelines.
 Literature search and presentation for new projects.
 Analyze the formulation strategy, efficiency, working relations and cross-functional issues
in R&D.
 Carry out stability studies at each stage of formulations development as per requirement.
 Resolve the problems and queries during product development by discussing with
team leader.
 Experienced in development of Immediate Release formulations like Tablets and
capsules for regulatory market in line with QbD concepts.
 Review, Compilation and discussion of analytical (In process, Initial and stability) reports.
 Preparation of R&D documents like MFR, and Product Development Report.
 Maintaining the stock cards and updating all the relevant registers as per SOP.
 Preparation of SOP’s, maintaining online documentation and respective logbook
entries according to GDP.

Projects Handled:
 Managing and comprehending the regulatory requirements with respect to the markets for
Solid oral products like tablets and capsules, Liquid oral products including suspensions,
solutions as well as injectables, and ophthalmic products.
 Successfully developed and executed Two Anti- Diabetic drug products.
 Developing and executing of Anti-Retroviral drug product.

Educational Qualification:

Year Course Institution Aggregate

University\Board
(%)
Acharya
M. Pharmacy Acharya Nagarjuna
2016-2018 Nagarjuna 90%
(Pharmaceutics) University
University
ASN Pharmacy Acharya Nagarjuna
2012– 2016 B-Pharmacy 75%
college, Tenali University
Sri Chaitanya, Board of Intermediate
2010-2012 Intermediate 82%
Vijayawada Education
ZPH School, Board of Secondary
2009-2010 SSC 75%
Emani Education
Skills & Strength:
 MS Office - Word, Excel, PPT
 Good in documentation and review.
 Good in English communication.
 Knowledge on regulatory requirements.
 Able to work in stressful situations.
 Team management and self-commitment.
 Maintain and follow checklist for every task.

Personal Details:

 Name : Sowmya Vallabhapurapu

 Father’s Name : Prasad Vallabhapurapu
 Date of Birth : 26th July 1995
 Gender : Female
 Language Known : Telugu, English, Hindi
 Marital status : Unmarried

Declaration:
I hereby declare that the above furnished data is correct and true to the best of my knowledge
and belief.

Date: (Sowmya Vallabhapurapu)

Place: