Kirtee Radadiya
CMC Regulatory Affairs
- Role
- Regulatory Affairs Cmc at Gilead Sciences
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Kirtee Radadiya
A regulatory professional with a background in Biotechnology/Pharmaceutical Sciences/Regulatory Science and 11+ years of CMC regulatory affairs and 2+ years of product development/analytical experience - Proven ability to effectively manage time, people and multiple projects. A dependable team player possessing regulatory skills and a comprehensive understanding of FDA, ICH and USP requirements- Extensive CMC Regulatory affairs experience through complete life-cycle management of products – Pre and Post Approval- Experienced with CMC regulatory strategy, filing original submissions (IND, CTA, IMPD, NDA, 505(b)(2), ANDA), Amendments, Annual Reprots, post-approval CMC changes, and eCTD - Global experience with submissions to multiple regions (US, EU, and ROW)Specialties: Regulatory Affairs, IND, CTA, IMPD, NDA, 505(b)(2), ANDA, CMC, Product Development, Analytical and Quality
Experience
Regulatory Affairs Cmc
Aug 2020 — Present
Extensive experience leading global CMC regulatory strategies across all stages of drug development and life cycle management- Strong knowledge of global regulatory requirements; led IND/IMPD submissions for US, EU, Canada, Asia, and LATAM- Directed RoW Clinical CMC Submissions knowledgebase at Gilead, including training and cross-functional coordination- Skilled in CMC strategy for combination products and health authority interactions, including FDA meeting packages- Led FDA CARES Act Amount Reporting and Serialization processes; supported Veeva implementation for change control- Prepares global submissions and responses in alignment with ICH and regional guidelines; collaborates cross-functionally- Mentors junior staff and manages regulatory data within validated RIMS systems.
Education
ICT (formerly known as UDCT), Bombay
M.Tech, Bioprocess Technology (Biotechnology - Downstream)
2003 — 2005
Sardar Patel University
B.S, Pharmacy
1999 — 2003
University of Southern California
Master of Science (MS), Regualatory Science
2008 — 2009
Skills
- Regulatory Submissions
- Regulatory Affairs
- Anda
- Pharmaceutical Industry
- Product Development
- Glp
- Fda
- Submission Management
- Ectd Submissions
- Quality Control
- Cmc Regulatory Affairs
- Ectd
- Gmp
- Technology Transfer
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