Global Regulatory Affairs Specialist

10 hours ago


Alleppey, Kerala, India beBeeRegulatory Full time ₹ 7,99,999 - ₹ 14,99,999

Regulatory Affairs Professional

We are seeking a highly skilled Regulatory Affairs (RA) Associate to support global market submissions.

The ideal candidate will have experience in managing submissions, variations, and lifecycle management activities for global markets.

Key Responsibilities:

  • Prepare variation documents and/or evaluate post-approval changes in compliance with regulatory requirements.
  • Contribute to lifecycle management activities by compiling and reviewing CTD dossier modules.
  • Compile initial dossiers for various countries.
  • Provide regulatory strategies and conduct evaluations of post-approval changes considering guidelines.
  • Manage compilation and submission of variations/supplements for different countries.
  • Utilize Veeva Vault RIM to track queries and manage submission workflows.
  • Review technical documents from manufacturing sites, including specifications, batch records, process & analytical validations, and stability data.

Requirements:

  • 3+ years of experience in managing submissions, variations, and lifecycle management activities.
  • Must have experience with Veeva Vault RIM.
  • Proficient in regulatory guidelines for various countries.
  • Hands-on experience in initial dossier compilation for various countries.
  • Experience in providing regulatory strategies/evaluation by performing assessment of post-approval changes.
  • Compilation and submission of variations/supplements as per applicable guidelines.


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