beBee background
Professionals
>
Mumbai
Alpana Kulkarni

Alpana Kulkarni

REGULATORY AFFAIRS PROFESSIONAL

Pharmaceutical / Bio-tech

Mumbai, Maharashtra

Social


About Alpana Kulkarni:

Experienced Regulatory Affairs Specialist with over 25 years in the pharmaceutical industry


 

Experience

CMC documentation, and cross-functional project coordination. Proven expertise in handling diverse markets including LATAM, CIS, MEA, and French West Africa. Demonstrates exceptional skill in dossier preparation, audit readiness, and compliance with global health authority requirements. Adept at team leadership and stakeholder communication across departments.


Education

MSc in Analytical Chemistry

Professionals in the same Pharmaceutical / Bio-tech sector as Alpana Kulkarni

Professionals from different sectors near Mumbai, Maharashtra

Other users who are called Alpana

Jobs near Mumbai, Maharashtra

  • Weekday AI Thane

    We are seeking an experienced Regulatory Affairs Executive – API to manage regulatory documentation and submissions for active pharmaceutical ingredients (APIs). Compile, prepare, and review regulatory documents including DMF, DCP, EDMF, and CEP for API products. · Ensure timely ...

  • Oxford Laboratories Pvt. Ltd. Mumbai, Maharashtra

    The Regulatory Affairs Manager will provide support to the Regulatory Affairs Manager and assist in independent preparation of CTD dossier along with complete regulatory compilation like Notarized / Apostle documents registration samples etc for timely registration of the product ...

  • Teva Pharmaceuticals Navi Mumbai, India,

    +Prepare submissions for post-approval activities and provide regulatory support to project teams. · +Create high-quality submissions in accordance with EU legislation and in-house standards. · Prioritize and monitor submission progress while documenting involved parties. · ...