Regulatory Affairs Manager – Early Access Programs – London or Remote - £competitive + benefits
My client, a leader in expanded access programs is now recruiting a Regulatory Affairs Manager / Senior Manager to join them on a permanent basis. The role is ideally based in London, but they can consider remote working too (UK only).
My client is a specialist in Expanded Access Programs, Named Patient Programs and Clinical Supplies. They are now recruiting a Regulatory Affairs Manager to join them permanently.
- Highly successful, rapidly growing pharma/clinical organisation
- Specialists in Managed Access Programs (MAP), Unlicensed Medicines Access, Clinical Trial Sourcing
- Offices in the UK (London) and the States
- Fully committed to employees career development and support internal progression
The Regulatory Affairs Manager is a critical hire for the company. You’ll ultimately be responsible for all regulatory matters, operational and strategically across the business.
- Provide guidance regarding current regulations (both UK and ROW) for pharmaceutical products
- Keep up to date with regulatory changes relating to unlicensed medicines
- Draft and maintain any regulatory policies, procedures, and SOPs
- Provide regulatory information to the wider business to assist with the overall Expanded Access Program (EAP) project design for clients.
- Provide regulatory advice directly to EAP clients
- Support the Project Management team with EAP and NPP Regulatory Submissions.
To apply for this role as Regulatory Affairs Manager our client is hoping for someone with the following skills and experience
- Previous Regulatory affairs experience
- Experience with expanded access programs, compassionate use, named patient programs, unlicensed medicines
- Regulatory strategy experience
- Experience liaising with the relevant health authorities across the UK/EU
- Life sciences degree
What should you do next?
This Regulatory Affairs Manager role is one not to be missed; it encompasses the opportunity to work in a highly successful, fast growing clinical / pharma company. To discuss this Regulatory Affairs Manager role further or to find out about other Regulatory Affairs jobs I’m currently working on, please get in touch or hit apply to submit your current CV.
Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.
Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.