Manager QREM & Pharmacovigilance
Core
Manage product-related regulatory and quality activities including registration submissions, renewals, change notifications, pharmacovigilance, regulatory audits, and adverse event reporting for medical devices and drugs in Pakistan.
Role type
Manager, Regulatory Affairs & Quality Assurance
Builds
Regulatory compliance and market access for medical devices and drugs in Pakistan
Domain
Healthcare / Medical Devices / Pharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device and drug registration, regulatory submission management, pharmacovigilance (PVRP/Dy PVRP), regulatory intelligence, quality management system (QMS) implementation, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), stakeholder management with health authorities, audit and inspection readiness, corrective and preventive actions (CAPA), import/export compliance
Preferred skills
Master's degree in quality/regulatory/science/pharmacy, ISO 13485 knowledge, MedTech experience
Technologies
Regulatory Information Management System (RIMS), MS-Office
Responsibilities
Liaise with health authorities (DRAP) for registration and approvals; maintain local registration dossiers and technical files; execute regulatory submission plans; manage pharmacovigilance activities including PSUR and RMP; ensure GMP/GDP compliance in labeling, warehousing, and distribution; manage customer complaints and adverse event reporting; prepare for internal and external audits; support tender processes and import/export operations.
Seniority
Manager, hands-on IC
