Regulatory Affairs Associate – Early Access / Named Patient Programmes – London (hybrid working 2 days pw in the office) - £negotiable + bonus, pension, healthcare, 25 days holiday

My client, a leader in managed / expanded access programs is now recruiting a Regulatory Affairs Associate to join them on a permanent basis. The role is ideally based in London, with hybrid working (2 days per week in the office.

The Company

My client is a specialist in Managed / Expanded Access Programs, Named Patient Programs and Clinical Supplies. They are now recruiting a Regulatory Affairs Associate to join them permanently.

• Highly successful, rapidly growing pharma/clinical organisation
• Specialists in Managed Access Programs (MAP), Unlicensed Medicines Access, Clinical Trial Sourcing
• Excellent career development/progression opportunities
• Offices in the UK (London) and the States

The Role

The Regulatory Affairs Associate is responsible for the following;

• Keep abreast of current regulations in the compliant movement of pharmaceutical products
• Communicate and liaise with regulatory agencies as needed to support the development of the regulatory database of country-specific information
• Support in the growth of the regulatory database of country-specific information
• Creation of country summaries, carrying out country-specific research as needed
• Keep up to date with regulatory changes towards the procurement, movement, and distribution of unlicensed medicines
• Provide regulatory support to the project management team.

You

To apply for this role as Regulatory Affairs Associate our client is hoping for someone with the following skills and experience

• Previous Regulatory affairs experience within clinical trials submissions
• Early phase 1-3 clinical trial experience
• Basic knowledge of GMP and GDP and MHRA Guidance Note 14
• Knowledge of or experience with expanded access programs, compassionate use, named patient programs, unlicensed medicines is highly desirable although not essential
• Experience liaising with the relevant health authorities across the UK/EU
• Life sciences degree

What should you do next?

This Regulatory Affairs Associate role is one not to be missed; it encompasses the opportunity to progress your Regulatory Affairs career within an innovative clinical company. To discuss this Regulatory Affairs Associate 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.