Senior Regulatory Affairs Officer

3 weeks ago

Karachi, Sindh, Pakistan Ghazi Brothers Full time

We are one of the leading pharmaceutical company in Pakistan. We require energetic and self-motivated individual for the following position to be based at Karachi.

Senior Regulatory Affairs Officer

Qualification:

  • Pharm-D

Experience:

  • 2 years

Responsibilities:

  • Lead the preparation, compilation, and review of regulatory dossiers for new product registrations, renewals, and variations in compliance with DRAP and international requirements.
  • Coordinate and follow up with local authorities (e.g., DRAP) to ensure timely product approvals.
  • Review and respond to complex queries from DRAP and other relevant authorities.
  • Maintain and oversee regulatory documentation, databases, and submission trackers.
  • File renewal and post-approval variations as per requirement.
  • Monitor and communicate changes in regulatory guidelines to ensure ongoing compliance.
  • Mentor and guide junior regulatory staff when required.

Skills:

  • Strong knowledge of DRAP regulations, CTD format, product registration, renewals, and variation processes.
  • Knowledge of international regulatory standards (WHO, ICH, FDA & EMA).
  • Strong project management and multitasking abilities.
  • Analytical and problem-solving mindset.
  • Excellent communication, coordination, and documentation skills.
  • Excellent writing skills for letter writing and argument handling.
  • Proficient in MS Office (Word, Excel & PowerPoint).

Send your CV with confidence at: Or apply online at:

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