Sun Pharmaceutical Industries Ltd
Designation : Executive
Function : Regulatory Affairs
Functional Area : RA
Job Role Summary : Compilation and review of dossiers, DMF for US, Europe, Japan and other markets , Evaluation and Categorisation of changes and variationsÂ
Job Profile :
- To evaluate and categories QMS related activities like Change Controls w.r.t. US/EDQM/Europe/UK/Australia/Japan/Korea/CADIFA/China/South Africa guidelines
- To Review, follow up and compilation of data for submission of USDMF, CEP, DCP, CP, MRP for New DMF submission and DMF-Amendment / Update based on the Planning
- To Review, follow up and compilation of data for submission of Japan, China, TGA, Canadian... for New DMF submission and DMF-Amendment / Update based on the Planning
- Compilation of raw data for Registration /re-registration and queries received from authorities for ROW market, such as China, Korea, Taiwan, Indonesia, South Africa...etc
Job Requirements :
- 2-5 years of Pharma regulatory affairs for APIs
- Data compilation and DMF preparation experience
Work / Job Experience : 2-5 Years
Type of Experience : Pharma Regulatory Affairs, Drug Master Files
Academic Qualifications :
M.Sc
