Sowjanya Vakalapudi
Regulatory Affairs Associate @Procell Biologics Pvt Ltd
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WORK HISTORY
Regulatory Affairs Associate @Procell Biologics Pvt Ltd
Hyderabad, IN
Prepare and review regulatory documentation for biologics and biosimilars in compliance with Indian regulations. Compile technical dossiers, stability data, CoAs, and product information documents. Collaborate with QA, QC, and R&D teams to ensure accurate, submission-ready documentation. Support product submissions, renewals, and variations, gaining strong experience in compliance-driven regulatory communication.
EDUCATION
Unisearch life sciences
Internship, Professional Medical Writing Training
Jawaharlal Nehru Technological University Hyderabad (JNTUH)
Master of Pharmacy (M.Pharm), Pharmaceutics
NIPER Hyderabad
Internship, QA & QC Training
Shri Vishnu College Of Pharmacy
Bachelor of Pharmacy (B.Pharm), Pharmacy
ABOUT SOWJANYA VAKALAPUDI
Regulatory Affairs and Medical/Scientific Writing professional with 1 year 5 months of industry experience in biologics and biosimilars, supporting regulatory documentation and compliance-driven content development. Hands-on experience in regulatory dossier support, data verification, label review, and structured scientific documentation, with formal training in Medical Writing, Clinical Data Management, and ICH-GCP. Strong academic research and publication background, with proven ability to transform complex scientific and regulatory data into clear, accurate, and submission-ready documents suitable for medical and regulatory writing roles.
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