Regulatory & Quality Manager – Pharmacovigilance (Pakistan)

About the role

Lead the regulatory and quality functions for medical devices and drugs in Pakistan, ensuring compliance with local and international standards while supporting product lifecycle, post‑market surveillance and pharmacovigilance activities.

Key responsibilities

• Manage medical device and drug registration with DRAP and other health authorities, including submissions, renewals and change notifications.
• Maintain up‑to‑date registration dossiers, technical files and regulatory resources in the Regulatory Information Management System (RIMS).
• Implement and monitor the Quality Management System (QMS) and ensure GMP/GDP compliance for labeling, warehousing and distribution.
• Act as Pharmacovigilance Responsible Person (PVRP), handling PSURs, RMPs, adverse event reporting and PV audits.
• Oversee product complaint handling, post‑market surveillance and regulatory intelligence updates.
• Prepare for and support internal and external audits, driving corrective and preventive actions as needed.

Required profile

• Degree in Pharmacy, Chemical, Bio‑engineering or related health field; master’s degree desirable.
• Minimum 8 years of industrial experience in medical devices or healthcare, with strong engagement with health authorities in South Asia.
• Proven experience leading regulatory negotiations and managing QMS implementations.

Required skills

• Medical device and drug registration processes.
• Regulatory submission planning and RIMS management.
• Quality Management System (QMS) implementation, ISO 9001, ISO 13485, ISO 31000.
• Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) knowledge.
• Pharmacovigilance activities: PSUR, RMP, adverse event reporting.
• Advanced MS‑Office proficiency.

What we offer

• Opportunities for self‑determined career planning and professional development.
• A corporate culture that encourages innovative thinking and collaborative solutions.
• Access to the resources of a global corporation combined with a collegial, medium‑sized company environment.
• Work alongside a large, committed team with diverse skills and experience.