Regulatory Affairs Manager - Pharmaceutical

12.0 - 15.0 years

8.0 - 10.0 Lacs P.A.

Pune, Mumbai (All Areas)

Posted:1 week ago| Platform: Naukri logo

Apply Now

Skills Required

Drug Regulatory AffairsDossier PreparationRow MarketRegistrationDossier CompilationFDALicensingRegulatory Submissions

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities B.Pharma / M.Pharma candidates with 12--15years experience in Regulatory Affairs for Asia & Africa, CIS markets & ROW market wrt to Compilation of dossiers in CTD, eCTD & national ,Compilation and submission of queries and variations. Review of documents, artworks Review of change controls Gap analysis for variation filing and maintaining product Life cycle. Preferred candidate profile Reputed Pharma background

RecommendedJobs for You