Manager QREM & Pharmacovigilance

Freseniusmedicalcare; Lahore; On-site; PKR 2,000,000 - 4,000,000; Full time

Job summary

Fresenius Medical Care in Pakistan seeks a Manager- Regulatory Affairs & Quality Assurance to lead regulatory submissions, pharmacovigilance, and QA activities for drugs and medical devices. You will collaborate with DRAP and other authorities to ensure compliance across product lifecycles.

The role includes implementing QMS, maintaining regulatory dossiers, and driving continuous improvement in regulatory processes within a global healthcare leader.

Qualifications

• Regulatory submissions and lifecycle management for drugs and medical devices.
• Implementation of QMS as part of regional quality initiatives.
• Regulatory intelligence and documentation governance.
• Audit readiness and liaison with health authorities.

Responsibilities

• Responsible for medical device and drug registration in Pakistan.
• Manage Regulatory Submission plan and RIMS for up-to-date product data.
• Maintain local registration dossiers and technical files for drugs and medical devices.
• Provide updates in Global Regulatory Roadmap and RIMS.

Skills

Regulatory affairs

Quality assurance

Pharmacovigilance

Regulatory submissions

GMP compliance

Tools

RIMS

Job description

Manager- Regulatory Affairs & Quality Assurance

Introduction: At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision-"Creating a future worth living. For patients. Worldwide. Every day."-we work with purpose and compassion, supported by a global team of over 125,000 employees. Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth. Our values guide how we work: We Care for our patients, each other, and our communities We Connect across teams and borders to deliver excellence together We Commit to doing things the right way- growing with purpose and leading kidney care with integrity and innovation

Information about Systems, Quality & Regulatory (SQR) department: Systems, Quality & Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care's products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle. The team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain, overseeing post-market surveillance, and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations. Join our passionate team and help shape healthcare worldwide!

Summary about role: Manage product related regulatory & quality activities e.g. registration submissions, renewals, change variations/notifications, PMS/PV activity, Regulatory Audits, adverse event/adverse drug reaction reporting, Pharmacovigilance responsible person, customer complaint handling, training, documentation management etc. in accordance with relevant regulations governing drug and device registrations in Pakistan.

Responsibility:

Your Responsibilities:

Main Activities:

• Responsible for Medical Device and Drug registration in Pakistan. Liaising with key health authority agencies (DRAP and other) during development, registration, and product lifecycle activities to resolve regulatory issues and/or negotiate approvals.
• Execution of Regulatory Submission plan. Manage Regulatory Information Management System (RIMS) to ensure all product information for medical devices and drugs is contemporaneous, accurate, and compliant to support uninterrupted market supply.
• Maintain up-to-date local registration dossiers, technical files, regulatory resources, and applicable legislation for both drugs and medical devices in the Pakistan and other distributors assigned.
• Provide regular updates in the Global Regulatory Roadmap and RIMS on the registration status of all products, including updates to the local country Roadmap.
• Implementation of Quality Management System (QMS) as part of a broader regional quality initiative.
• Implementation of the Regulatory Intelligence System, ensuring timely review, assessment, and integration of all relevant regulatory updates.
• Ensure all labelling/ redressing activities are conducted in full compliance at warehouse with Good Manufacturing Practice (GMP) requirements.
• Responsible for regulatory affairs and quality tasks like management of product complaints and product regulatory conformity, safety, and post market systems in Pakistan, communication to applicable SysQaRa functions in accordance with corporate SOPs.
• Monitor regulatory compliance of distributors and critical suppliers
• Fulfil PVRP/ Dy PVRP (Pharmacovigilance responsible person) responsibilities which includes submission of PSUR, RMP, participate in PV audit, implementation of PV SOPs, Quarterly compliance, communication with CDS (Corporate Drug Safety) etc.
• Report customer complaints, incidents and any potential safety issues in compliance with corporate SOPs and execute medical device incident/adverse event reporting in compliance with local country regulations.
• Ensure audit and inspection readiness including preparation, realization and follow-up of external and internal audits and inspections. In case of detected deviations and non-conformities, ensure the effective, efficient and timely implementation of required corrections, corrective and/or preventive actions.
• Ensure safe, compliant and efficient release and distribution of products imported and marketed by FME within the distribution quality function. Ensure the fulfillment of GDP requirements for distribution of medical devices and drugs.
• Participate in monthly Quality and Regulatory Affairs (QaRa) meetings to provide regulatory compliance updates, share insights, and support cross-functional al