PAYAL SANTWANI (Executive RA)
2.5 years experience
PROFESSIONAL EXPERIENCE
Work History:
Executive- Regulatory affairs Jan 2015 鈥� May 2016
Teva Pharm, India
Officer- Regulatory affairs Sept 2013 - November 2014
ELC Research s.r.o. (Mumbai)
Job Profile: EU market
1. Maintenance of MRP/DCP Procedures (Generics) for Europe market.
2. Regulatory application preparation for DCP, MRP, Duplicate, National and RUP submissions
3. Publishing the sequence and submissions for European countries in accordance with international regulatory guidelines
4. Liaising with the medical team for safety related queries (SPC and PIL)
5. Hands on experience in SPC and PIL writing
6. High proficiency wi...
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