At a Glance
- Tasks: Lead global regulatory strategies for innovative biologics and advanced therapies.
- Company: Global biotechnology company focused on rare and serious diseases.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Dynamic role with excellent career advancement potential.
- Why this job: Make a real impact in the biotech field while collaborating with international teams.
- Qualifications: Experience in Regulatory Affairs CMC and strong communication skills.
The predicted salary is between 60000 - 80000 £ per year.
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 will 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 other teams.
Senior Regulatory Affairs Manager CMC biologics employer: Hays Life Sciences
As a leading global biotechnology company, we pride ourselves on fostering a dynamic and inclusive work environment that encourages innovation and collaboration. Our employees benefit from comprehensive professional development opportunities, competitive compensation packages, and the chance to work on groundbreaking therapies that make a real difference in patients' lives. Located in a vibrant area with access to top-tier resources and a supportive community, we are committed to empowering our team members to thrive both personally and professionally.
