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Regulatory Compliance Associate

3 weeks ago

Bengaluru, Karnataka, India Biocon Full time
Role Overview

The Regulatory Compliance Associate role at Biocon involves ensuring compliance with regulatory guidelines and requirements related to post-approval activities.

Responsibilities:

  • Ensure compliance with post-approval regulatory requirements.
  • Prepare and submit regulatory documents, including PADERS, annual reports, and PSURs.
  • Maintain up-to-date knowledge of regulatory guidelines and requirements.
  • Assess change controls and provide regulatory assessments.
  • Supervise team members on compilation of regulatory dossiers.
  • Coordinate with cross-functional teams to finalize supplements.
  • Ensure timely submission of responses to agency deficiencies.
  • Identify and assess regulatory risks associated with assigned projects.

Requirements:

  • Hands-on experience managing post-approval activities.
  • Well-versed with regulatory guidelines.