Regulatory Affairs Senior Manager EU in Slough

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