Hays Specialist Recruitment Limited
Your new company
Our client, a global biotechnology company focused on developing innovative therapies for rare and serious diseases, is seeking an experienced Regulatory Affairs CMC Manager to join their EU Regulatory team.This is an excellent opportunity to contribute to cutting-edge biologics and advanced therapies, supporting global post-approval strategies and new market applications across both EU and US regions.
Your new role
Reporting to the Senior Director, Regulatory Affairs CMC (EU), you will play a key role in delivering global regulatory CMC strategies for commercial products. You'll collaborate with international teams across Europe and the US to ensure successful execution of regulatory submissions and lifecycle activities.
- Act as the Regulatory CMC representative at site and cross-functional meetings, providing clear regulatory guidance.
- Lead the planning, coordination, and compilation of high-quality CMC documentation for global post-approval submissions
- Ensure all submissions comply with relevant regulatory requirements and guidelines (EU, FDA, and global standards)
- Partner with international teams to support change controls and GMP documentation
- Contribute to global product registrations, renewals, and lifecycle management
- Identify potential risks and proactively develop mitigation strategies
- Support interactions with global regulatory authorities
- Maintain strong collaboration across regulatory, technical, and operational teams
What you'll need to succeed
- Strong experience in Regulatory Affairs CMC, ideally within biologics, biotechnology, or advanced therapies
- Demonstrated experience with post-approval submissions and lifecycle management
- Significant FDA experience is essential, alongside a solid understanding of EU regulations.
- Proven ability to manage complex projects and global stakeholders
- Excellent communication and organisational 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.
To apply for this job please visit www.reed.co.uk.
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