Purva Arsekar
Regulatory Specialist CTA/ IND Development Delivery at GSK
- Role
- Regulatory Specialist-i Cta (Clinical Trials Application) Ind Development Delivery at GSK
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Purva Arsekar
Into nuances of experiences when working as a Regulatory Affairs Professional in the…
Experience
Regulatory Specialist-i Cta (Clinical Trials Application) Ind Development Delivery
May 2022 — Present · Mumbai, IN
Acting as Submission lead.Responsible for: coordination, development, refinement of the CTA lifecycle strategy, timely content & delivery appropriate to each individual regulatory agency while maintaining compliance with GSK policy and procedures.Working on Clinical Trial Directive, DIA TMF Reference Model and CTA submission requirements for multiple countries/submission types.
Education
University of Mumbai Vivekanand education society's college of pharmacy
M.pharm, Quality Assurance
2015 — 2017
I.E.S's.V.N.Sule.Guruji English Medium-KIng George School, Hindu Colony,Dadar
SSc., Mathematics and Computer Science
University of Mumbai Vivekanand Education Society s College of Pharmacy
B.pharm, Pharmacy
2010 — 2014
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