Global leading specialist Pharmaceutical company need a dedicated Regulatory Affairs Manager/Associate.
The intial contract will be 2 months and the role will be paid as an hourly rate contractor (INSIDE 35). The role involves managing regulatory aspects within a small UK regulatory department. The team handles a diverse product portfolio, primarily focused on haemophilia, immunology, and respiratory products.
Responsibilities include life cycle management, variation submissions, labelling updates, and collaboration with global regulatory colleagues.
You will also be required to interact with cross-functional teams, including quality, medical, marketing, and pharmacovigilance.
Specific product allocation involves managing all lifecycle (LCM) aspects and queries. Labelling management, involvement in medical device work, and occasional clinical trial support are also part of the role.
- Labelling preparation - checking leaflets, packaging, SmPCs, print releases, etc.
- EU / UK regulatory submission processes - new licences, variations, renewals
- Working with different types of licences - MR/DC/Centralised/National
- Working with MHRA
- Brexit and GB requirements
- Medical device knowledge
- PIP experience
- Liaising with other functions - PhV, Quality, Commercial
- Good experience with different regulatory systems such as Veeva, packaging systems, submission systems
- Biological product experience
- UK affiliate experience
Desired qualifications include experience in labelling preparation, EU/UK regulatory processes, working with MHRA, and knowledge of medical devices.
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