GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 5000 people. Globally, we are a 27.4 billion EUR, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders.
Post : Executive - Regulatory Affairs
Job Description
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, its status & archival on GSK Global RA Systems
Candidate Profile
Minimum - B.Pharm
Preferred - Post graduate in Pharmacy Or Science
Additional Information
Qualification : B.Pharm, M.Pharm, M.Sc
Location : Worli Mumbai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 15th October, 2022
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