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Position: Sr Regulatory Specialist – Variations

Location: Mumbai, Maharashtra, Bangalore, Karnataka, INDIA

Job Description:

Key Responsibilities:

  • With minimal input from the manager, executes agreed dossier strategy
  • With minimal input from the 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 the manager, completes data assessment to ensure the dossier is fit for purpose.
  • With minimal input from the manager, identifies risks associated with submission data and information packages.
  • Communicates with the line managers 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 the manager regarding project and policy issues ensuring the optimum position for GSK.

Desired Candidate Profile:

  • Minimum 4-5 years of relevant experience
  • Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
  • Global/ EMAP Regulatory submission experience – Knowledge of regulatory agency guidelines
  • Excellent organizational skills, attention to detail and commitment to deliver high-quality output, even under pressures sometimes demanded by regulatory deadlines
  • Excellent written and verbal communication skills and ability to present information in a clear and concise manner
  • Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience
  • Ability to build effective working relationships and work in a matrix environment effectively
  • Ability to think flexibly in order to meet constantly shifting priorities and timelines.

 

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