Regulatory Affairs Specialist

1 day ago

Bareilly, Uttar Pradesh, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,12,000
Regulatory Affairs Specialist

We are seeking a detail-oriented Regulatory Affairs - CMC (Chemical, Manufacturing and Controls) Specialist to support end-to-end submissions for global markets.

The successful candidate will be responsible for preparing Variation documents and/or evaluating post-approval CMC changes in compliance with global regulatory requirements.

  • Lifecycle Management (LCM)
  • Veeva Vault RIM
  • Compiling and reviewing initial dossiers (Modules 2 & 3) for US / EU / SA / WHO / ANZ / Other Countries.
  • Providing regulatory strategies and conducting evaluations of post-approval CMC changes considering ICH and country-specific guidelines.
  • Managing compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries.
  • Utilizing Veeva Vault RIM to track queries and manage submission workflows.
  • Reviewing technical documents from manufacturing sites including specifications, batch manufacturing records, process & analytical validations, batch analysis data, and stability data.

Key Responsibilities:

  • Manage Initial Submissions, Variations, and full LCM deliverables for global markets.
  • Experience with Veeva Vault RIM is required.
  • Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ANZ/Other countries.
  • Review of technical documents from manufacturing sites required 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.

Requirements:

  • Minimum 3 years of experience in managing Initial submissions, Variations, and full LCM deliverables for the global markets.
  • Must have experience with Veeva Vault RIM.
  • Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ANZ/Other countries.
  • Review of technical documents from manufacturing sites required 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.

About This Role:

This is an exciting opportunity to join our team as a Regulatory Affairs Specialist. If you have a strong background in regulatory affairs and excellent communication skills, we encourage you to apply.

We offer a dynamic and supportive work environment, competitive salary, and opportunities for professional growth and development.

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