Global Regulatory Compliance Specialist

1 day ago


Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878

Job Title: Regulatory Affairs Associate I

About the Role:

We are seeking a highly motivated and detail-oriented Regulatory Affairs Associate I to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with regulatory requirements and developing strategies to mitigate potential risks.

Key Responsibilities:

  • Evaluate change controls for registration impact and ensure implementation of necessary dossier changes in Europe and International Markets.
  • Compile variation packages for products in the portfolio in collaboration with relevant stakeholders.
  • Manage regulatory databases and Trackwise system efficiently.

Requirements:

  • Academic degree with a chemical/pharmaceutical background.
  • 2-5 years of experience in CMC Regulatory Affairs, focusing mainly on Europe and International Markets.
  • Proficient in registration procedures and pharmaceutical regulations.
  • Familiarity with Document Management Systems.
  • Strong prioritization skills and ability to adhere to timelines.
  • Capable of working independently with moderate guidance.
  • Problem-solving abilities and implementation of process improvements.
  • Team player mentality.

Reporting Structure:

This role reports directly to our Senior Manager CMC Regulatory Affairs.



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