Sofi Joseph

Head Of Regulatory Affairs And Pharmacovigilance


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.