Global Regulatory Affairs Specialist

2 weeks ago

Vellore, Tamil Nadu, India beBeeRegulatoryAffairs Full time ₹ 18,00,000 - ₹ 24,00,000
Job Description

We are seeking a highly skilled Regulatory Affairs Specialist to support end-to-end submissions for global markets. The ideal candidate will have experience in managing initial submissions, variations, and full lifecycle management deliverables.

The successful candidate will possess strong knowledge of ICH guidelines and regulatory requirements for global markets. They will also be familiar with Veeva Vault RIM and have hands-on experience in initial dossier compilation for various countries.

Responsibilities:

  • Prepare variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
  • Contribute to lifecycle management activities by compiling and reviewing CTD dossier modules.
  • Compile initial dossiers (Modules 2 & 3) for submission to US / EU / SA / WHO / ANZ / Other Countries.
  • Provide regulatory strategies and conduct evaluations of post-approval CMC changes.
  • Manage compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries.
  • Utilize Veeva Vault RIM to track queries and manage submission workflows.
Required Skills and Qualifications

Experience Requirement:

  • Minimum 3+ years of experience in managing initial submissions, variations, and full lifecycle management deliverables.
  • Proven experience with Veeva Vault RIM and regulatory guidelines for US/EU/SA/WHO/ANZ/Other countries.
  • Strong understanding of ICH guidelines and regulatory requirements for global markets.
  • Hands-on experience in initial dossier compilation for US/EU/SA/WHO/ANZ/Other countries (Module 2 & 3).
  • Ability to provide regulatory strategies and evaluations of post-approval CMC changes.
Benefits

The successful candidate will receive a competitive compensation package and opportunities for professional growth and development.

Others

This role is an exciting opportunity for a motivated individual to join our team and contribute to the success of our organization.

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