Swati Agrawal
Global Regulatory Affairs CMC (Vaccines, Biologics, small molecules, Oncology)
- Role
- Senior Director, Global Regulatory Affairs Cmc at BioNTech SE
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Swati Agrawal
Pharmaceutical Regulatory Professional with 15+ years of experience in CMC and regulatory CMC within the industry and the FDA- Experience in leading global regulatory submissions for various stages of submission including INDs, IMPDs, EUAs, BLAs and MAAs in close collaboration with in-house CMC, Clinical Development, Clinical Operations, Manufacturing, Supply Chain and Quality teams, contract manufacturing organizations, external experts, collaborators, and strategic partners- Mentoring and leading high performance teams to accomplish goals in line with company vision.
Experience
Senior Director, Global Regulatory Affairs Cmc
Aug 2025 — Present · Boston, MA, US
Education
Birla Institute of Technology and Science, Pilani
M.S., Pharmacy
Dr. A.P.J. Abdul Kalam Technical University
B.S., Pharmacy
Virginia Commonwealth University
PhD, Pharmaceuticals
Virginia Commonwealth University
Doctor of Philosophy - PhD, Pharmaceutical Sciences
Skills
- New Chemical Entities and Generics
- Tga
- Rheology
- Lipid Based Drug Delivery
- Differential Scanning Calorimetry
- Hplc
- Preformulation and Formulation
- Powder X-Ray Diffraction
- Nanotechnology
- Cgmp Manufacturing
- Nanoparticles
- Particle Engineering
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