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Position: Consultant Specialist CMC Renewals

Location: Bangalore, Karnataka, India

Job Description:

Key Responsibilities:

  • With minimal input from the manager, executes the agreed dossier strategy.
  • Manages multiple project assignments (e.g., Variations <CMC & Therapeutic>, Product Expansion dossiers, Renewals, MSRs) simultaneously; dossiers will range in complexity.
  • Completes data assessment to ensure the dossier is fit for purpose. 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.

Job-Related Experience:

  • 4 – 7 years Experience in  Regulatory Submission- Initial submissions, Variations, Renewals,  for Europe(Mandatory), Rest Of the World & US region markets
  • Understanding and hands-on experience in Product registration dossier/ CTD module
  • Hands-on experience in different types of certificates, declarations, and legalized documents – both QA & RA documents.
  • Experience in direct interactions with various on-site stakeholders in GRPD departments

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