Sanyam Gandhi

Master’s degree in pharmacy with 12 years of Hands on experience in Regulatory Affairs-, Pharma, Biotech, Rare Diseases and Generics. • Regulatory Affairs Experience in Strategic planning and Project Management with emphasis on Executing Regulatory strategies, CMC-CTA authoring, and submissions. • Early Sate Development: MAA planning, IMPD, Investigational Brochure, Scientific discussion and meeting with health Authorities, CMC Strategy, Local requirements. • Post approval: Variations, PSUR Submissions, Safety updates, CCDS update, Site transfer project, Change controls, Annual reports, GAP Analysis, Renewals, compliance support. • Adept in Regulatory systems i.e. Documentum, Track-Wise, Opal, IMMS. Web center • Certified in many regulatory and project management courses with RAPS (USA), TOPRA (UK) and Management forum. • Direction oriented, Individual contributor and excellent team player PROFESSIONAL