Urgent opening for Regulatory Affairs Pharma Industry Vadodara

Opening: Regulatory Affairs
Experience required: 3 to 6 years
Location: Vadodara

Required Knowledge:
Preparation of Dossiers for Advanced / Emerging / Regulated ROW Market as per prevailing guidelines.
Candidate must have core understanding of the technical requirements in the CTD
Coordinate with QA/QC/CVS and associated departments to facilitate the dossier requirements.
Preparation / Review of DMF(s), and follow up to make them compliant to target country
Response to Queries from MoH or Customer.
Setting of specification and Protocols to harmonize RA requirements.
Review of process validation protocol, stability protocol, BMR, and other directly or indirectly linked Quality section in CTD/ACTD.
Manage the lifecycle of a product including variation and renewals.
Experience in handling markets like Brazil, South Africa, Malaysia, Singapore, Saudi Arabia (GCC), Russia (CIS) etc are preferred.
Candidates must be capable to stand-along deliver the required dossier with minimal input from Line Manage.

Qualification: MSc / B. Pharm / M. Pharm

If you are interested then send me your updated Resume on rect8@saigroupbrd.com OR call on 9227475124.