SOFI JOSEPH, Regulatory Affairs & Pharmacovigilance Director, Servier

An established professional with over 25 years of experinece in Regulatory Affairs, Pharmacovigilance, & Clinical Trials; acknowledged for providing strategic direction for the Regulatory, Pharmacovigilance (PV), Clinical Operations, New drug development & Due diligence of pharmaceutical products

•   Product registrations, their lifecycle maintenance and defense.
•   Clinical operations and Pharmacovigilance
•   Strategy and Project planning
•   Coordinating and supporting the implementation of regulatory strategies to ensure successful on time submissions
•   WHO prequalification’s and Emerging markets submissions
•   International as well as Domestic Regulatory filing and health authority interactions
•   Expertise in regulatory filings for Clinical trials, BA/BE studies, New Chemical entities, Active Pharmaceutical Ingredient ( API) , Formulations, Biotech Products, Cosmetics and Food supplement
•   Environmental shaping with industry bodies and health authorities
•   Audit and compliance
•   Due diligence for in-licensing / out-licensing molecules
•   Product development

Organizations worked with in the past: Torrent Pharmaceuticals, Hester Biosciences, Biological Evans, Glenmark Pharmaceuticals, Pfizer Limited.

Current Organization: Servier India Pvt Ltd since April 2017 as Regulatory and Pharmacovigilance Director (Formerly known as Serdia Pharmaceuticals ( India ) Private Limited)

Educational: Master’s Degree in Pharmacy form L.M College of Pharmacy, Ahmedabad , Diploma in Regulatory Affairs and Certification in advanced clinical trial monitoring