Global Regulatory Affairs Specialist

4 days ago

Mount Abu, Rajasthan, India beBeeRegulatoryAffairs Full time ₹ 20,00,000 - ₹ 25,00,000

Job Opportunity:

We are seeking a detail-oriented Regulatory Affairs professional to support end-to-end submissions for global markets. The ideal candidate will have experience with Lifecycle Management, Veeva Vault RIM, and complex Initial and Variation submissions.

Key Responsibilities:

  • Prepare regulatory documents and evaluate post-approval CMC changes in compliance with global regulatory requirements.
  • Contribute to Lifecycle Management (LCM) activities by compiling and reviewing CTD dossier modules.
  • Compile initial dossiers for US/EU/SA/WHO/ANZ/Others 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/Others 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 Requirements:

  • 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/Others Countries.
  • Hands-on experience in initial dossier compilation for US/EU/SA/WHO/ANZ/Others 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/Others Countries as per applicable regulatory guidelines.

The ideal candidate will have excellent communication skills, be able to work in a team environment, and possess a strong attention to detail.

About the Role:

This role is an excellent opportunity for a motivated and experienced Regulatory Affairs professional to take their career to the next level. If you have a passion for regulatory affairs and a desire to make a meaningful contribution to the industry, we encourage you to apply.

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