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Regulatory Affairs Specialist

2 weeks ago

Morādābād, Uttar Pradesh, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,00,000
Regulatory Affairs Professional

This position involves managing Initial submissions, Variations, and full LCM deliverables for global markets.

Key responsibilities include preparing Variation documents and evaluating post-approval CMC changes in compliance with global regulatory requirements. Additionally, the successful candidate will contribute to Lifecycle Management activities by compiling and reviewing 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.

The ideal candidate will have experience with Veeva Vault RIM and proficiency 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, stability etc. is also required for compilation of dossier sections/Variations.

Required Skills and Qualifications:
  • 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.
Benefits:

The company offers a competitive compensation package and opportunities for career growth.