Job Description

Responsibilities : To prepare dossiers as per CTD/ACTD guidelines for product registration, renewal & variation applications to submit in regulated / semi regulated countries. To arrange administrative documents required for dossier submission & export purpose (Manufacturing Lic, WHO-GMP, P.P/COPPs/FSCProcuring and legalization). To check & approve the artworks for regulated / semi regulated countries. To Co-ordinate and follow-up with manufacturer for documents & samples/WS required for regulatory submission. Handling queries pertaining to regulatory submissions from various regulatory authorities. Maintain record of samples, shade cards, registration certificate etc. Desired profile of the candidate : - Should have good communication skill. Good technical knowledge, review skills, and understanding of regulatory submissions. Good leadership and organizational skills, with a strong focus on execution and follow-through. Minimum Exp. : - 8 years in Regulatory Affairs Maximum Exp. : - 15 years in Regulatory Affairs Education : - B.Pharma / M.Pharma / B.Sc / M.Sc