Global Regulatory Compliance Specialist

5 hours ago

Belgaum, Karnataka, India beBeeRegulatory Full time ₹ 10,00,000 - ₹ 15,00,000
Job Title:

Regulatory Affairs Specialist

We are seeking a skilled Regulatory Affairs Specialist to support end-to-end submissions for global markets.

This role is ideal for individuals with experience in managing initial submissions, variations, and full lifecycle management deliverables for global markets.

About the Role:
  • Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
  • Contribute to Lifecycle Management (LCM) activities by helping to compile and review 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.
  • 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.
Key Qualifications:
  • 3+ years of experience in managing Initial submissions, Variations, and full LCM (Lifecycle management) deliverables for the global markets.
  • Must have experience with Veeva Vault RIM.
  • Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ANZ/Other countries.
  • Hands-on experience in initial dossier compilation for US/EU/SA/WHO/ANZ/Other 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/Other countries as per applicable regulatory guidelines.

This is an excellent opportunity for those looking to grow their careers in regulatory affairs. The right candidate will be part of a dynamic team responsible for ensuring compliance with global regulatory requirements.

If you're passionate about regulatory affairs and have the required skills and experience, we encourage you to apply for this exciting opportunity.

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