Senior Regulatory Affairs Manager
Our biotech client, with manufacturing facilities just outside London, is currently investing significantly in their manufacturing programme. This state-of-the-art facility houses high-technology and next-gen processes to produce drugs that are distributed throughout the Globe. The site is easily reachable by two major airports and has excellent transport links throughout.
The client is currently seeking the expertise of a Senior Regulatory Affairs Manager due to their rapidly growing team!
In this role you will be responsible for the line management of a team of permanent staff members, helping to manage their goals, objectives and training needs. You will oversee all licensing activities throughout the product range. Along with this you will ensure proper process and systems are in place to manage all regulatory activities related to drug licenses.
You will have the following experience/qualifications:
- 7-10 years experience within Regulatory Affairs
- Demonstratable experience with managing business critical and complex drug development projects and licensing activities
- Broad knowledge of regulatory filing strategies
- Demonstrable team leadership skills
- Project Management skills are desirable
- Substantial experience in obtaining and maintaining product licenses worldwide and obtaining clinical trial authorisations in key markets (EU, US )
- Substantial knowledge of current drug regulations in key markets (US, EU,)
- Substantial experience of dealing and negotiating directly with Health Authorities in key markets (EU, US)
Our client, based in leafy Hertfordshire, is now looking for a Head of Drug Safety to join their team on a permanent basis. We are looking for candidates who would be able to manage and have overall
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Do you relish the opportunity to work with a leading UK based Biologics manufacturer? If yes, then this is the assignment for you! Our biotech client with manufacturing facilities just outside
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