Asst-Manager Drug Regulatory Affairs_ GHC/KSA_

4 hours ago

Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time

Job Purpose
The Asst. Manager – Regulatory Affairs (GHC/KSA) will lead regulatory strategy, submissions, and compliance for pharmaceutical products intended for the ROW markets. This is an onsite role based in Gurgaon. The individual will serve as a key regulatory liaison, ensuring products meet all regulatory requirements, supporting lifecycle management, and facilitating timely approvals by the relevant authorities.

Key Responsibilities

  • Review of eCTD/CTD dossiers, variations, change controls, renewals and ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
  • Regulatory authoring excellence: Administrative part, labelling, technical writing, formatting per GCC templates.
  • Tracking and responding to Authority queries within stipulated timelines; leading cross-functional action plans.
  • Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
  • Collaborate with internal and external clients via project trackers.
  • Demonstrate subject matter and area expertise.
  • Supporting and enabling effective and efficient communication that results in operational excellence.
  • Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies' website.
  • Educational Qualifications: B.Pharm / M.Pharm

Why Join Us

  • Opportunity to contribute to key regulatory submissions
  • Exposure to global health authority expectations
  • Skill development and continuous learning environment
  • Collaborative work culture

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