about 1 year ago
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.
- 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.
- 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.firstname.lastname@example.org