Home Regulatory Affairs Consultant – Regulatory Specialist CMC Renewals | Glaxo SmithKline | Bangalore

Consultant – Regulatory Specialist CMC Renewals | Glaxo SmithKline | Bangalore


Our goal is to be one of the world’s most innovative, best performing, and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences, and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good, and keep growing.

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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