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 : Sr Executive – Regulatory Affairs ( API )
Location : Mumbai Suburbs
Experience : 3 – 7 Years
Job Description:
- Preparation & Compilation of DMF for US market in coordination with plant regulatory affairs. [Review and compilation of all the documents received from plant, R&D and other departments as per regulatory requirement]
- Preparation of anticipated queries based on compilation and current query trend.
- Preparation of Technical Packages of API products for customers as per marketing requirement.
- Review and response to the deficiencies received from regulatory authorities.
- Responsible for post approval changes like review and discussion of change controls for its comments to assign applicable change category & Annual Update / Renewal of DMFs [USDMF]
Qualifications:
- UG -B.Pharma – Pharmacy, B.Sc – Any Specialization
- PG – MS/M.Sc(Science) – Any Specialization, M.Pharma – Pharmacy
