GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 5000 plus 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 Affairs
Job Description :
Job Purpose
• Responsible for the CD regulatory delivery activities (e.g., Variations CMC & Therapeutic, Product Expansion dossiers, Renewals) of assigned projects with minimal input from line manager.
• Supports Global Regulatory by producing appropriate components for global regulatory dossiers with minimal input from line manager.
• Has training responsibilities for new staff on established departmental processes.
Key Responsibilities
Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role With minimal input from manager, executes agreed dossier strategy With minimal input from manager, manages multiple project assignments (e.g., Variations CMC & Therapeutic, Product Expansion dossiers, Renewals) simultaneously; dossiers will range in complexity With minimal input from manager, completes data assessment to ensure dossier is fit for purpose. With minimal input from manager, identifies risks associated with submission data and information packages. 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
Master degree Area of Specialisation Chemistry, pharmacy or other related science or technical bachelors degree.
Masters degree or higher in biological or healthcare science.
Minimum 5 years of experience
Knowledge of drug development and manufacturing and supply processes.
Knowledge of worldwide CMC regulatory requirements.
Additional Information
Experience : 5 years
Qualification : M.Pharm, M.Sc
Location : Bengaluru
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th April, 2022
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