Regulatory Affairs Executive Vacancy – Pharma Candidates Apply
GSK hiring Regulatory Affairs. Regulatory Affairs job opening 2022. Executive – Regulatory Affairs job opening 2022, Pharmacy job opening 2022, M Pharmacy job opening 2022, Executive – Regulatory Affairs job opening 2022. Executive – Regulatory Affairs job. Check out all the details on the same below:
Job Title: Executive – Regulatory Affairs
Location: Worli Mumbai, India
Department: Regulatory
Id: 339188
Qualifications:
Minimum- B Pharm
Preferred- Post graduate in Pharmacy Or Science
Responsibilities:
1. Assist the Regulatory Affairs Manager in fulfilling regulatory responsibilities for activities related to Clinical Trials and its lifecycle management of Pharmaceuticals, Biopharm and Vaccine assets for India.
2. Compile Regulatory Dossiers for:
Clinical Trial Applications (Phase Ib/II/III/PMS) – Global pipeline assets
Clinical Trial Applications – local Phase 3 and Phase 4 studies to support registration
Central Drug Laboratory (CDL) Applications for Clinical Trial Lot releases for vaccine assets
Maintenance Applications- Protocol amendments, Compliance Notifications in line with NDCT Rules 2019, CT Variations
Clinical Trial Post-approval commitments
3. Review and approval of CT labels in line with NDCT Rules 2019
4. Liaise with Global Regulatory Affairs (GRA) team for Regulatory requirements of various submission activities
5. Ensure regulatory compliance to
requirements of Drugs and Cosmetics Rules, especially NDCT Rules for GSK studies approved by DCGI.6. Tracking of Projects:
Track and maintain the local XL database for the projects assigned
E2E management of CT-related submissions, it’s status & archival on GSK Global RA Systems
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