Regulatory Affairs AD EU (12m Contract)

Your new company

You 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.

• 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.

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.

#4660560 - Julia Bowden