Regulatory Affairs Senior Manager EU

Your new company
An exciting opportunity has arisen for an experienced EU Regulatory Affairs Senior Manager to join a leading global biopharmaceutical organisation. This is a pivotal role where you'll shape and execute EU regulatory strategy across both clinical development and life cycle management, working at the heart of innovative product pipelines.

Your new role
As a key member of the regulatory team, you will partner with cross-functional stakeholders to drive successful submissions and ensure compliance across EU markets. You'll play a strategic and hands-on role, influencing programmes from early development through to post-approval lifecycle activities.Key Responsibilities

• Lead the planning, coordination and preparation of EU regulatory submissions, supporting EU Regulatory Leads
• Contribute to the development and execution of EU regulatory strategies aligned to business objectives
• Identify and assess regulatory risks, proposing effective mitigation strategies
• Represent Regulatory Affairs on cross-functional project teams and governance forums
• Drive alignment across regulatory functions and stakeholders
• Provide expert regulatory guidance throughout R&D and product lifecycle
• Engage with Health Authorities, partners and external stakeholders representing the organisation
• Build and maintain strong relationships with regulatory agencies and collaborators
• Support and lead health authority meetings, inspections and audits
• Monitor the evolving EU regulatory landscape and assess impact on development programmes.
• Ensure compliance with internal policies and external regulatory requirements

What you'll need to succeed

• Degree in Life Sciences (or related discipline)
• Solid grounding in Regulatory Affairs, including EU submissions (preferred)
• Strong knowledge of EU regulations, guidelines and regulatory processes
• Experience interacting with regulatory authorities.
• Excellent communication and stakeholder management skills
• Ability to work independently and within cross-functional teams
• Highly organised with strong attention to detail and prioritisation skills
• Comfortable operating in a multicultural, matrix environment

What you'll get in return
Flexible working options available.

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 us for a confidential discussion about your career.