Manisha Jaykar
Global regulatory submission
- Role
- Regulatory Affairs at Cipla
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
Experience
Regulatory Affairs
Apr 2006 — Present
The Role: Generic Product Registration with ROW Health Agencies through as per defined procedure & Post authorisation life cycle maintenance for product (including variations, renewal etc.). Responsible for dossier preparation and compilation for ASEAN countries (Phillipines), Sri lanka, Oman, Belarus, Regulated market South Africa (MCC) with in the stipulated time. Handling of queries, Art work development, review of documents, etc. Post approval changes, Variation, renewal submission. Reviewing the Pharmaceutical, Clinical, Bioequivalence data received from unit. Maintaining the registration certificate, preparing regulatory status, monthly planning for dossier submission.Highlights: Registration and submission of dossier with ASEAN (Philippines), Srilanka, Oman, Belarus, Regulated market South Africa (MCC). Post approval variation, renewal etc.
Education
Bombay College of Pharmacy (BCP)
Bachelor’s Degree, Pharmacy
I.E.S New English School
SSC, SSC
1991 — 1992
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