Sakshi Mayekar
Regulatory Affairs at Cipla
- Role
- Associate Director Regulatory Affairs at Cipla
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Sakshi Mayekar
As an Associate Director at Cipla, my role encompasses managing global registration…
Experience
Associate Director Regulatory Affairs
Jan 2017 — Present
Group Leader for API regulatory affairs requirement. Current Job responsibility - Managing a team for Global registration requirement for DMF compilation, new registrations, Amendments submissions, life cycle management and support to key vendor qualifications. Provide technical support for regulatory agencies assessment comments/response submissions till final approvals. Also provide technical support for new development at R&D, Technology Transfer, specification establishment etc.
Education
Mumabai
Master’s Degree
Skills
- Regulatory Requirements
- Regulatory Affairs
- Ectd
- Anda
- Generic Programming
- Technology Transfer
- Glp
- Validation
- Pharmacovigilance
- Gmp
- Capa
- Regulatory Submissions
- Pharmaceutical Industry
- Sop
- Fda
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