Senior Regulatory Affairs Specialist

1 day ago


Bikaner, Rajasthan, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,40,00,000

Global Regulatory Expertise

We are seeking a detail-oriented professional to support end-to-end submissions for global markets.

Key Responsibilities:

  • Prepare and Evaluate Regulatory Documents: Contribute to the compilation and review of regulatory documents, ensuring compliance with global regulatory requirements.
  • Lifecycle Management: Assist in compiling and reviewing CTD dossier modules, utilizing lifecycle management best practices.
  • Initial Dossier Compilation: Prepare initial dossiers (Modules 2 & 3) for US / EU / SA / WHO / ANZ / Other Countries, adhering to regulatory guidelines.
  • Regulatory Strategies: Develop and implement regulatory strategies for post-approval CMC changes, considering ICH and country-specific guidelines.
  • Submission Management: Oversee the compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries.
  • Document Review: Conduct thorough reviews of technical documents from manufacturing sites, including specifications, batch manufacturing records, process and analytical validations, batch analysis data, and stability data.

Requirements:

  • 3+ years of experience in managing Initial submissions, Variations, and full Lifecycle Management 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.
  • Review of technical documents from manufacturing sites, including specifications, batch manufacturing records, validations, batch analysis data, and stability data, is 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.

Skills and Qualifications:

  • Strong understanding of regulatory requirements and guidelines.
  • Excellent communication and documentation skills.
  • Ability to work effectively in a team environment.
  • Proficiency in MS Office and/or Google Suite.
  • Experience with Veeva Vault RIM and other regulatory software tools.


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