Regulatory Officer – Pharmaceutical Industry

Position: Regulatory Officer
Industry: Pharmaceutical
Location: Karachi
Job Type: Full-time

We are seeking a knowledgeable and detail-oriented Regulatory Officer to support regulatory affairs and ensure full compliance with national and international pharmaceutical guidelines.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers for drug registration, renewals, and variations.
• Ensure compliance with DRAP (Drug Regulatory Authority of Pakistan) and other relevant global regulatory guidelines (FDA, WHO, ICH where applicable).
• Maintain and update regulatory documentation, product files, and technical records.
• Coordinate with R&D, Quality Assurance, Quality Control, and Production teams to gather required data.
• Track and manage timelines for submissions, approvals, and regulatory commitments.
• Review and approve product labels, packaging, leaflets, and promotional materials to ensure regulatory accuracy.
• Support internal and external audits, including GMP inspections.
• Monitor changes in pharmaceutical regulations and communicate updates to relevant teams.
• Ensure timely renewal of registrations, licenses, certifications, and regulatory submissions.

Requirements

• Bachelor’s/Master’s degree in Pharmacy (Pharm-D preferred).
• Minimum 1–3 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Strong knowledge of DRAP rules, GMP guidelines, and ICH standards.
• Excellent documentation, dossier preparation, and technical writing skills.
• Ability to manage deadlines and work cross-functionally.
• Strong communication and attention to detail.

Job Type: Full-time

Pay: Rs80,000.00 - Rs100,000.00 per month

Work Location: In person