At a Glance
- Tasks: Lead lifecycle management and regulatory submissions for innovative healthcare products.
- Company: Join a leading healthcare organisation with a focus on innovation.
- Benefits: Enjoy flexible working options and opportunities for career growth.
- Other info: Be part of a collaborative environment that values continuous improvement.
- Why this job: Make a real impact in regulatory affairs while managing a dynamic team.
- Qualifications: Experience in EMEA Regulatory Affairs and strong stakeholder engagement skills.
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.
Regulatory Affairs Manager OTC in Reading employer: Hays Life Sciences
Join a leading healthcare organisation that values innovation and collaboration, offering a dynamic work environment for Regulatory Affairs professionals. With flexible working options and a strong focus on employee growth, you'll have the opportunity to lead lifecycle management strategies while mentoring a small team. This role not only allows you to contribute to meaningful projects across the EMEA region but also ensures you stay at the forefront of evolving regulatory frameworks.
