Sofi Joseph
Head Of Regulatory Affairs And Pharmacovigilance
Serdia
Serdia House, Off. Dr. S.S. Rao Road, Parel, Mumbai 400 012 India
Expertise across various regulatory domains both local (India), emerging as well as regulated markets: in Regulatory Affairs, Pharmacovigilance and Clinical trials.
Have over 20 years of experience in the Pharmaceutical industry: national as well as MNC with experience in the following areas of regulatory Affairs:
- Strategy and Project planning
• Coordinating and supporting the implementation of regulatory strategies to ensure successful on time submissions
• Product registrations, their lifecycle maintenance and defense.
• WHO prequalifications 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
• Clinical operations and Pharmacovigilance
• Environmental shaping with industry bodies and health authorities
• Audit and compliance
• Due diligence for in-licensing / out-licensing molecules
• Product developmentOrganizations worked with in the past: Torrent Pharmaceuticals, Hester Biosciences, Biological Evans, Glenmark Pharmaceuticals, Pfizer Limited.Current Organization: Serdia Pharmaceuticals (India) Private Limited since April 2017 as Head Regulatory and Pharmacovigilance
Educational: Master’s Degree in Pharmacy form L.M College of Pharmacy, Ahmedabad, Diploma in Regulatory Affairs and Certification in advanced clinical trial monitoring.
