Sofi Joseph

Head Of Regulatory Affairs And Pharmacovigilance

Serdia

Serdia House, Off. Dr. S.S. Rao Road, Parel, Mumbai  400 012 India

http://www.serdiapharma.com/

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.