Job Description

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