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Your new companyYou will be joining a leading biopharmaceutical company dedicated to developing innovative therapies for patients with serious and life-threatening conditions. This company is renowned for its commitment to scientific excellence and patient-centric approach.
Your new role
As the EU Regulatory Lead, you will manage the regulatory strategy for a molecule with three related indications.
Your responsibilities include:
- Leading EU regulatory activities for clinical trials and ensuring timely submissions.
- Collaborating cross-functionally to implement regulatory changes.
- Representing the EU regulatory team in cross-functional meetings.
- Supporting other programs in various development stages and post-approval activities.
- Aligning with Global and US Regulatory Leads for successful outcomes.
What you'll need to succeed
- 10+ years of experience in Regulatory Affairs
- In-depth knowledge and experience with EU regulatory requirements and procedures.
- A proven track record of developing, implementing, and communicating regulatory strategies.
- Excellent documentation skills to ensure high-quality and timely submissions.
- Experience with EU guidance and leading regulatory processes, particularly in clinical trials and Type II variation submissions.
- Global experience, including collaboration with US regulatory teams, is highly advantageous.
In return, you will receive:
- 12-Month Contract with attractive rates
- Scope for extension past 12 months
- A hybrid flexible model, with opportunities for remote working in the UK.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.If this job isn't quite right for you, but you are looking for a new position, please contact Julia Bowden for a confidential discussion about your career.
