Job title: Associate Director, Regulatory Affairs

A global biopharmaceutical company in Berkshire are seeking a Regulatory Affairs Project manager to join their growing team. This role will be responsible to lead the UK/IE regulatory affairs function in the post EU environment. The ideal candidate will have significant experience in the planning and execution of regulatory activities in UK/IE markets.

Responsibilities:

• Lead and develop a small team of regulatory affairs professionals in the post-EU exit environment.
• Identify changes to both EU and UK regulatory legislation and guidance and implement any required changes to local processes.
• Deliver regulatory submissions, i.e. variations, marketing authorisation applications, renewals, education materials, PIP and orphan submissions, clinical trial applications.
• Develop and maintain an effective relationship with the MHRA and HPRA.

Requirements:

• Extensive industry experience in regulatory affairs in the UK/IE environment.
• A deep understanding of the post-EU regulatory environment in the UK (GB & NI).
• Experience liaising with the MHRA/HPRA.
• Previous line management experience would be beneficial.

Salary and benefits:

A highly competitive salary and wider benefits scheme is on offer

To apply for this position or hear further details then please contact Freddie Hill via Freddie.hill@pharma-partners.co.uk