Regulatory Affairs Manager

About the role

The Regulatory Affairs Manager at Hamdard Pakistan oversees all regulatory processes for pharmaceutical products, ensuring compliance with national authorities and industry standards.

Key responsibilities

• Manage product registrations, renewals and all regulatory submissions to meet timelines.
• Coordinate with DRAP and other agencies to address queries and ensure compliance.
• Review and approve labeling, packaging and regulatory documentation.
• Lead preparation for inspections and audits, responding to findings promptly.
• Develop regulatory strategies for new product development and maintenance.

Required profile

• Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences or related field.
• Minimum eight years of experience in the pharmaceutical industry, preferably in regulatory affairs.
• Proven leadership and communication skills to manage a team of five professionals.

Required skills

• In‑depth knowledge of regulatory requirements and compliance processes.
• Experience with product registration, renewal and submission procedures.
• Familiarity with DRAP regulations and interaction with regulatory bodies.