Sun Pharma an international,specialty pharmaceutical company headquartered in India with a global manufacturing network across 25 countries. We manufacture and market a large basket of pharmaceutical formulations as branded generics & generics in India, US and across the world.
Job Title : Senior Research Scientist – Regulatory Affairs-labeling
Location : Gurgaon
Experience : 2 – 6 Years
No.of.Openings : 02
- Ensure timely completion of labeling for ANDA/NDA/ANDS dossiers for submissions without screening deficiencies and prepare response to labeling deficiencies to secure approval.
- Manage & coordinate commercial launch activities for new & existing approval Rx/OTC product for SPIL/Acquired products/customers/printers
- Ensure timely completion of brand name/physical samples for NDA projects.
- To provide labeling inputs to MACR for PVG.
- Manage OTC Labeling on day-to-day basis in co-ordination with marketing team/Graphics team and maintain the records of the same
- Ensuring timely information of Artwork approvals through approval package upon receipt of approval and update the same based on renewals and variations
Coordination with various departments for preparation of variation packages (specifically wrt labeling part) and submit the same to regional offices.
- UG -B.Pharma