Regulatory & Pharmacovigilance Manager (Pakistan)

About the role

Fresenius Medical Care is seeking a Manager to lead regulatory affairs, quality assurance, and pharmacovigilance activities for both medical devices and pharmaceuticals in Pakistan. The role ensures compliance with local regulations, supports product lifecycle management, and safeguards patient safety.

Key responsibilities

• Manage medical device and drug registration processes with the Drug Regulatory Authority of Pakistan (DRAP) and other health agencies.
• Prepare and submit registration dossiers, renewals, change notifications, and post‑market surveillance reports.
• Execute the regulatory submission plan and maintain up‑to‑date technical files and regulatory resources.
• Oversee the Regulatory Information Management System (RIMS) to keep product information accurate and compliant.
• Handle adverse event reporting, pharmacovigilance responsibilities, and customer complaint investigations.
• Coordinate regulatory audits, training, and documentation management.
• Provide regular updates to global teams on local regulatory status.

Required profile

• Proven experience in medical device and drug registration within Pakistan.
• Familiarity with DRAP regulations and other relevant health authority requirements.
• Ability to liaise with regulatory agencies and negotiate approvals.
• Strong organizational skills to manage multiple regulatory submissions and post‑market activities.

Required skills

• Regulatory Information Management System (RIMS) usage.
• Pharmacovigilance processes and adverse event reporting.
• Medical device registration procedures.
• Pharmaceutical registration procedures.