Regulatory Affairs Manager OTC

Your new company
Are you an experienced Regulatory Affairs professional looking to take ownership of lifecycle strategy across a dynamic EMEA portfolio? We're partnering with a leading healthcare organisation to find a Regulatory Affairs Consultant - LCM to join their growing team.
This is a fantastic opportunity to play a key strategic and operational role across product lifecycle management, working at the intersection of CMC, regulatory strategy, and cross-functional collaboration. You'll contribute to both innovation and maintenance of existing products while managing a small team.

Your new role
Key Responsibilities
Lifecycle Management & Submissions

• Lead end-to-end lifecycle management activities including variations, renewals, labelling updates, and aggregate reports
• Prepare and submit variation applications via EU procedures (MRP/DCP, Workshare), including complex submissions and super-groupings.
• Develop submission strategies, including reference member state selection and regulatory pathways
• Support marketing authorisation applications for early-stage innovation projects

Regulatory Strategy

• Provide strategic regulatory input and technical CMC guidance to cross-functional stakeholders
• Partner with product development teams to define regulatory requirements, risks, and timelines
• Contribute to the design and execution of development programmes across the EMEA region

Compliance & Governance

• Ensure compliance with EU and global regulatory requirements and maintain inspection readiness
• Stay up-to-date with evolving regulatory frameworks, advising the business on impact and opportunity
• Oversee and maintain accuracy of regulatory systems and documentation
• Support audits and ensure SOP adherence and continuous process improvement

What you'll need to succeed

• Proven experience in EMEA Regulatory Affairs, ideally within lifecycle management
• Strong knowledge of EU regulatory procedures (MRP/DCP, variations, PSUSA/aggregate reports)
• Demonstrated ability to develop and execute regulatory strategy across complex submissions
• Experience in line management or mentoring junior team members
• Excellent stakeholder engagement and cross-functional collaboration skills

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.