Manager QREM & Pharmacovigilance

Manager- Regulatory Affairs & Quality Assurance

Responsibilities

Your responsibilities include:

• 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 c...