Global Regulatory Compliance Specialist

5 days ago

Thrissur, Kerala, India beBeeRegulatoryAffair Full time ₹ 15,84,000 - ₹ 21,58,000

As a detail-oriented Regulatory Affairs professional, you will play a crucial role in supporting end-to-end submissions for global markets.

The ideal candidate will have experience with lifecycle management (LCM), Veeva Vault RIM, and complex initial and variation submissions.

Key responsibilities include:

  • Prepare Variation Documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
  • Contribute to Lifecycle Management Activities by helping to compile and review CTD dossier modules.
  • Compile Initial Dossiers (Modules 2 & 3) for US / EU / SA / WHO / ANZ / Other Countries.
  • Provide Regulatory Strategies and conduct evaluations of post-approval CMC changes considering ICH and country-specific guidelines.
  • Manage Compilation and Submission of Variations/Supplements for US/EU/SA/WHO/ANZ/Other countries.
  • Utilize Veeva Vault RIM to Track Queries and Manage Submission Workflows.
  • Review Technical Documents from Manufacturing Sites, including specifications, batch manufacturing records, process & analytical validations, batch analysis data, and stability data.

Experience Requirement:

  • A minimum of 3 years of experience in managing initial submissions, variations, and full LCM deliverables for global markets.
  • Must have experience with Veeva Vault RIM.
  • Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ANZ/Other countries.
  • Ability to review technical documents from manufacturing sites for compilation of dossier sections/variations.
  • Hands-on experience in initial dossier compilation for US/EU/SA/WHO/ANZ/Other countries (Module 2 & 3).
  • Experience in providing regulatory strategies/evaluation by performing assessment of post-approval CMC changes considering global regulatory requirements.
  • Compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries as per applicable regulatory guidelines.

This is a challenging and rewarding opportunity for an experienced Regulatory Affairs professional who is passionate about ensuring the quality and compliance of medical products.

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