Job for M.Pharm, M.Sc Assistant Manager in Regulatory Affairs at GSK Rx India
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, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders.
Post : Assistant Manager – Regulatory Affairs
Job description
Preparation of registration dossier for securing licenses for new product introduction as well as life cycle management of imported Pharma and Biological (Vaccines and r-DNA derived) products for domestic (India) market.
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.
Candidate Profile
• Post graduate in Pharmacy or Science
• Approx. 4-5 years of experience in handling regulatory dossier preparation and filing with CDSCO office for imported assets preferably in the biological space
• 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
Additional Information
Location : Worli Mumbai
Qualification : M.Pharm, M.Sc
Experience : 4-5 years
Req ID : 247107
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 10th April, 2020
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