Walker Cole International are searching for a Regulatory Affairs Manager to join a UK-based pharmaceutical distribution company. As a Regulatory Affairs Manager, you will ensure compliance with all regulations and laws governing the parallel import of medicines.
Key responsibilities as the Regulatory Affairs Manager:
- Preparing and submitting regulatory filings and documentation to appropriate regulatory agencies (MHRA).
- Monitoring and interpreting regulatory requirements and communicating changes to stakeholders.
- Submitting variations for PLPI licenses timely and liaising with QA and Warehouse on the status (to quarantine or to process pending variation).
- As the Regulatory Affairs Manager, you will be managing packaging components stock levels, including monitoring stock levels, ordering components (cartons, labels, braille labels), and replenishing stock according to stock management sheets.
To be successful in your application for the Regulatory Affairs Manager you will have the following expertise:
- A Bachelor's degree (or equivalent) in a related field.
- Industry experience in parallel imports or regulatory affairs.
- Strong understanding of quality assurance principles in parallel imports.
Regulatory Affairs | Parallel Import | Variations | MHRA | Pharmaceutical Distribution | Compliance | PLPI Licenses | Regulatory Submissions