GSK Pharma Regulatory Affairs Manager Post Vacancy – Apply
Pharma Assistant Manager Regulatory Affairs. GSK invites postgraduate and undergraduate Pharma candidates for the post of manager. Interested and Eligible candidates in the field of the pharma may apply for this post. Check out all the details on the same below:
Job Title: Assistant Manager – Regulatory Affairs
Location: Worli Mumbai, India
Department: Regulatory
Job Id: 247107
Education: Postgraduate in Pharmacy or Science
Job-Related Experience :
Approx. 4-5 years of experience in handling regulatory dossier preparation and filing with CDSCO office for imported assets preferably in the biological space
Other Job-Related Skills/Background:
- Good knowledge of Drugs and Cosmetic Acts and Rules with respect to new drug permission, import and registration and life cycle management
- Proficiency in spoken and written English
- Project management skills
- Hands-on experience of handling SUGAM portal
Responsibilities
- Assist the Regulatory Affairs Manager in fulfilling regulatory responsibilities for activities related to registration of new drugs and lifecycle management of Biologicals [Vaccines and Biopharm] and Pharmaceuticals for domestic market.
Compile Regulatory Dossiers for offline as well as online submission (SUGAM) of: - New Drug Registration (NDA), Clinical Trial Applications (IND), Registration Certificates and Import Licenses
- Renewals of Registration Certificates/Import Licenses
- Manufacturing Variations
- Clinical Trial Maintenance applications
- Prescribing Information Updates
- Post-approval commitments
- Review and approval of artworks for assigned products.
- Liaise with Global Regulatory Affairs (GRA) team for Regulatory requirements of various submission activities
- Ensure compliance to GSK processes as well as requirements of Drugs and Cosmetics Acts and Rules for the assigned products & projects
- Track and maintain the NPI activities and product lifecycle on local XL database for the projects assigned
- Track and maintain submission and approval status & follow-ups on GSK Global RA Systems.
Job Purpose:
Preparation of registration dossier for securing licenses for new product introduction as well as life cycle management of imported Pharma and Biological (Vaccines and rDNA derived) products for domestic (India) market.
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