Regulatory Compliance Specialist

3 days ago

Aligarh, Uttar Pradesh, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

We are seeking a detail-oriented Regulatory Affairs Associate to support end-to-end submissions for global markets.

Key Responsibilities:
  • 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 various countries including the US, EU, SA, WHO, ANZ, and others.
  • 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 various countries including the US, EU, SA, WHO, ANZ, and others.
  • 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.

The ideal candidate will have experience in managing Initial submissions, Variations, and full Lifecycle Management deliverables for the global markets.

Required Skills and Qualifications:
  • Experience with regulatory affairs, particularly in preparing Variation documents and evaluating post-approval CMC changes.
  • Knowledge of global regulatory requirements and guidelines, such as ICH and country-specific regulations.
  • Ability to work in a team environment and contribute to Lifecycle Management activities.
  • Excellent communication and organizational skills, with attention to detail and ability to meet deadlines.

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