Require Regulatory Specialist at GlaxoSmithKline Pharmaceuticals Ltd

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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. At GSK, our mission is to improve the quality of life by enabling people to do more, feel better and live longer. This mission drives us to make a real difference to the lives of millions of people with our commitment to effective healthcare solutions.

Post : Regulatory Specialist

Job Description
• Communicates with line manager to identify issues that have business impact.
• May have dossier review responsibilities for peers and may identify improvement opportunities for Regulatory processes, policies and systems.
• Developing an understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global regulatory applications.
• Understands internal/external Regulatory environment.
• Actively builds an organizational network.
• Communicates across GSK, with minimal input from manager regarding project and policy issues ensuring optimum position for GSK.

Candidate Profile
Minimum 6 yrs of experience in CMC variation in all the markets
•  With minimal input from manager,executes agreed dossier strategy  manages multiple project assignments (e.g., Variations <CMC & Therapeutic>, Product Expansion dossiers, Renewals, MSRs <CMC&non-CMC>) simultaneously; dossiers will range in complexity completes data assessment to ensure dossier is fit for purpose. identifies risks associated with submission data and information packages.

Additional Information
Experience : 6 years
Qualification : B.Pharm, M.Pharm, M.Sc
Location : Karnataka - Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 30th September, 2019


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