Regulatory Affairs Manager

About the role

The Regulatory Affairs Manager will lead all regulatory activities for new plant licensing, product registrations and documentation of new molecules within a reputable pharmaceutical organization. You will act as the primary liaison with the Drug Regulatory Authority of Pakistan (DRAP) to ensure timely submissions, approvals and renewals.

Key responsibilities

• Manage new plant licensing processes and ensure compliance with DRAP regulations.
• Lead registration of new pharmaceutical products and new molecule documentation.
• Prepare and maintain all regulatory dossiers, technical files and supporting documentation.
• Correspond with DRAP for submissions, approvals, renewals and any other regulatory inquiries.
• Monitor changes in pharmaceutical legislation and update internal processes accordingly.

Required profile

• 5 to 7 years of experience in regulatory affairs within a reputable pharmaceutical company.
• Strong knowledge of DRAP regulations and overall pharmaceutical legislation.
• Excellent regulatory writing and documentation skills.

Required skills

• Proficiency in DRAP regulatory requirements.
• Experience with pharmaceutical product registration.
• Strong documentation and technical writing abilities.
• Effective communication and correspondence with regulatory authorities.