Regulatory Affairs Manager UK and Ire

Your new company

Our client, a highly regarded Regulatory Affairs consultancy, is seeking an experienced Regulatory Affairs Manager to support a fast-paced and growing generics pharmaceutical company across the UK and Ireland markets.

This is an excellent opportunity for a regulatory professional with strong post-approval and life cycle management experience to work within a dynamic environment where regulatory excellence and business agility are key to success.

Your new role

• Lead and manage post-approval regulatory activities across the UK and Ireland portfolios.
• Prepare, review and submit regulatory variations, renewals and other life cycle maintenance activities.
• Coordinate and manage submissions in accordance with MHRA and applicable EMA requirements.
• Ensure regulatory compliance and maintenance of marketing authorisations across multiple products and markets.
• Own regulatory labelling activities, ensuring compliance with UK national requirements and relevant EU guidance.
• Provide regulatory intelligence and strategic advice on evolving UK and Ireland regulatory frameworks.
• Support inspection readiness, governance initiatives and ongoing compliance activities.
• Partner closely with cross-functional teams including Quality, Supply Chain, Medical Affairs and Commercial functions to deliver submissions on time and to a high standard.
• Monitor and assess post-Brexit regulatory developments and their impact on product registrations and life cycle activities.

What you'll need to succeed

• We are looking for a regulatory professional who can demonstrate:
• Extensive experience supporting UK and EU regulatory affairs activities, particularly variations, renewals and life cycle management.
• A proven track record of preparing and managing post-approval submissions within generics or branded pharmaceutical environments.
• Strong working knowledge of MHRA procedures and EU regulatory requirements.
• Expertise in regulatory labelling and maintenance of compliant product information.
• In-depth understanding of the evolving post-Brexit UK regulatory landscape, including UK national procedures and EU reliance considerations.
• Experience operating within highly regulated pharmaceutical environments with a strong focus on governance and compliance.
• Excellent stakeholder management skills and experience coordinating cross-functional project teams.
• Strong organisational skills with the ability to manage multiple priorities in a fast-moving environment.
• Regulatory Affairs Manager level experience within the pharmaceutical industry.

What you'll get in return: Remote working, outside IR35