Regulatory Affairs UK Specialist

Role Overview

We are currently looking for a Regulatory Affairs UK Specialist to join a leading Pharmaceutical company based in the Berkshire area, for an initial 12 months. As the Regulatory Affairs UK Specialist you will be responsible for acting as point of contact for Regulatory Strategy within the UK (MHRA) Market. This is fantastic opportunity to join a great company with strong product pipeline.

Key Duties and Responsibilities

Your duties as the Regulatory Affairs UK Specialist will be varied however the key duties and responsibilities are as follows:

1. Develop Regulatory strategies for the UK Market using your excellent knowledge in the UK Market and MHRA regulations and processes.

2. Assess changes due to Brexit and how these will affect clinical and marketed product activities

3. The Regulatory Affairs UK Specialist will be a commercially savvy individual, with a strong ability to work alongside other departments such as Regulatory Operations, Patient Safety an build internal networks.

4. Proactively advise other departments on potential risks and advise on contingency plans.

Role Requirements

To be successful in your application to this exciting opportunity as the Regulatory Affairs UK Specialist we are looking to identify the following on your profile and past history:

1. Relevant degree in a Scientific-related discipline

2. Proven Regulatory Affairs experience with Pharmaceutical, Biotechnology or CRO industries (At least 5 years)

3. A working knowledge and practical experience with Clinical Trial Applications and the UK Market. Brexit experience is highly advantageous


Key Words: Reg Affairs / RA / Regulatory Affairs / Regulatory / Pharmaceutical / CRO / Biotechnology / Clinical / CTA / Remote / Contract / MHRA / UK / Brexit / Regulatory Strategy / Regulatory Intelligence