Anima Mohapatra
@animamohapatra
Regulatory Affairs Specialist with 10.5 years of experience.
IndiaWhat I'm looking for
I am a Regulatory Affairs Specialist with over 10.5 years of experience in preparing and authoring dossiers for diverse international markets, including Europe, Brazil, LATAM, and Central America. My strong project management and strategic thinking skills ensure timely submissions and compliance with regulatory guidelines such as ICH-Quality. I excel in handling complex technical documents and coordinating with cross-functional teams to support regulatory submissions.
Throughout my career, I have demonstrated proficiency in using software tools like LIMS, SAP, DoruBridge, and PharmaREADY to enhance efficiency. My career goals include advancing my expertise in global regulatory affairs to drive successful product launches. I have successfully prepared and reviewed dossiers for various markets, ensuring compliance with country-specific guidelines and timely submissions.
Experience
Work history, roles, and key accomplishments
Regulatory Affairs Specialist
Dr. Reddy's Laboratories Ltd
May 2022 - Present (3 years 2 months)
Prepared and authored dossiers for the Brazil market as per ANVISA Checklist and ICH M4, and for other countries including Chile, Colombia, and Ecuador. Assessed and evaluated change controls and categorized variations according to country-specific guidelines.
Regulatory Affairs Executive
Medreich Limited
Feb 2019 - Present (6 years 5 months)
Authored Module 1 to Module 3 sections for the European market, ensuring timely submissions. Reviewed and handled CMC for European markets and its application in CMC writing, ensuring adequacy of plant and regulatory documents as per CHMP (EMEA) quality guidelines.
Regulatory Affairs Officer
Macleods Pharmaceuticals Limited
Apr 2017 - Present (8 years 3 months)
Authored Module 2 to Module 3 sections for Europe, Australia, and Canada markets, ensuring timely submissions. Prepared responses to regulatory queries for these regions and reviewed CMC for European markets.
Regulatory Affairs Executive
Celogen Life Science and Technologies Pvt. Ltd
Jan 2015 - Present (10 years 6 months)
Authored Module 1 to Module 3 sections for the UK market, ensuring timely submissions. Prepared RFI responses to regulatory queries for the UK market.
Education
Degrees, certifications, and relevant coursework
School of Pharmaceutical Sciences
Master's degree, Pharmaceutics
Completed a Master's degree in Pharmaceutics, focusing on advanced pharmaceutical sciences. Gained in-depth knowledge of drug formulation, development, and regulatory aspects.
Indira Gandhi Institute of Pharmaceutical Sciences
Bachelor of Pharmacy, Pharmacy
Obtained a Bachelor of Pharmacy, covering fundamental principles of pharmaceutical science. Developed a strong foundation in pharmacology, medicinal chemistry, and pharmaceutics.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
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