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 : Regulatory Specialist, CMC Renewals - Senior
• Responsible for the GRPD regulatory delivery activities (e.g., Variations <CMC & Therapeutic>, Product Expansion dossiers, Renewals, MSRs <CMC&non-CMC>) 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.
• 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, MSRs <CMC&non-CMC>) 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.
• Minimum 5 years of experience
• Knowledge of worldwide CMC regulatory requirements.
Job ID : 282077
Experience : 5 years
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory
End Date : 30th March, 2021
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