Swaroopa Paratkar Email & Phone Number

Passionate about leveraging my extensive expertise in product development and global regulatory affairs with a mission to deliver robust therapeutics to benefit patientsDirector of Regulatory Affairs-CMC with extensive experience in CMC development, regulatory strategy, and complex project leadership in the biologics and cell & gene therapy sectors. Proven track record in optimizing operational workflows, leading high-performing teams, and driving successful global regulatory submissions for major pharmaceutical companiesAreas of expertiseBiologics | Cell & Gene Therapy | Project management| Program management| GMP Manufacturing | Product Development | Life Cycle Management| Drug-device combinations| Chemistry, Manufacturing and Controls (CMC)| CMC Regulatory Strategy | Regulatory and ICH guidelines| Regulatory Compliance| People Leadership/management

Listed skills include Protein Chemistry, Drug Development, Protein Characterization, Process Simulation, and 5 others.