Senior Regulatory Affairs Professional

8 hours ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,50,000

Regulatory Affairs Associate Manager Job Description

We are seeking a highly skilled Regulatory Affairs Associate Manager to lead our team in Hyderabad, India. The successful candidate will be responsible for regulatory activities related to chemistry, manufacturing, and control (CMC).

Main Responsibilities:

  • Author high-quality global CMC documentation for Health Authority submission throughout the product lifecycle.
  • Apply agreed-upon CMC global regulatory strategies, current regulatory trends, and guidelines.
  • Ensure technical congruency and regulatory compliance, meeting agreed-upon timelines and e-publishing requirements.
  • Identify required documentation and any content, quality, or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
  • As needed, coordinate, collect, store source documentation needed for direct submission to Health Authorities.
  • Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy, identifying critical issues and lessons learned.
  • Perform activities in support of the overall department, such as data entry into the Regulatory Information Management System, other CMC database entry, or maintenance and operational activities as needed.
  • Reporting of technical complaints, adverse events, special case scenarios related to products within 24 hours of receipt.
  • Distribution of marketing samples where applicable.

Key Performance Indicators:

  • Produces high-quality regulatory documentation.
  • No delays in approvals of clinical studies, global registration dossiers, or variations due to late or inadequate submission documentation on matters within RA CMC control.
  • Delivers reliable, timely, and accurate information and communication about project documentation specific issues within own department and to key stakeholders.
  • RA CMC regulatory documentation follows guidelines and meets regulatory guidelines.
  • Built and maintains collaborative partnerships with stakeholders.

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