Senior Regulatory Compliance Specialist

3 days ago

Anantapur, Andhra Pradesh, India beBeeRegulatory Full time US$ 90,000 - US$ 1,20,000

Job Title: Regulatory Affairs

 

About the Role:

We are seeking a detail-oriented RA Associate to support end-to-end submissions for global markets. Required exposure includes Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.

Main Responsibilities:

  • 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, Stability Data.

Key Qualifications:

  • 3+ years of experience in managing Initial submissions, Variations, and full LCM 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.

About the Position:

This is an exciting opportunity to join our team as a Regulatory Affairs Associate. If you have a strong background in Regulatory Affairs and are looking for a new challenge, we encourage you to apply.

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