Dy. Manager/ Manager- Drug Regulatory Affairs

Job description Dy. Manager/ Manager- Drug Regulatory Affairs - Team Lead position Role & responsibilities Responsible and Accountable for Preparation/compilation of registration, re-registration dossier and variation application as per assigned projects Preparation, Review and compilation of Registration, Re-registration dossier as per registration guidelines for various countries. Preparation and compilation of dossier products for registration in various countries Handling of variation application for assigned countries. Coordination with plant to fulfill document requirements for query responses of assigned projects Conduct thorough reviews of artwork pertaining to New registrations, Re-registrations, and variations for the assigned projects. Arrange and dispatch of product Sample along with supporting documents to various countries. Initiate Change control in QAMS and prepare TI sheet upon receiving approvals for new registrations, re-registrations, and variations in the assigned countries. To ensure timely submission of GMP application for various countries. Preparation & updation of Budget, Quarterly & Monthly presentation/plan, Product Registration Status, Payment Status, PIF, PIF1A for African Countries. Review of API documents for African Countries. Any other assignment allocated by HOD. Key Challenges: Coordination with plants regarding document requirements for dossier preparation and query response. Coordinate with regulatory team for regulatory activities & international plant for CMC data. Regular follow-ups & co-ordination with Technical Team of Plant & API Vendor for the Technical Documents and timely submission to MOH. Role: Healthcare & Life Sciences - Other Industry Type: Pharmaceutical & Life Sciences Department: Healthcare & Life Sciences Employment Type: Full Time, Permanent Role Category: Healthcare & Life Sciences - Other Education PG: M.Pharma in Pharmacy Key Skills Skills highlighted with ‘‘ are preferred keyskills Dossier PreparationDossier CompilationGmp Compliance Drug Regulatory AffairsRegulatory AffairsPIF1A