Job Description

Title: Senior Manager, CMC Regulatory Strategy
Company: Ipsen Biopharm Ltd
About Ipsen:
Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.
Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company's success. Join us on our journey towards sustainable growth, creating real impact on patients and society!
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At Ipsen, we are committed to improving the lives of patients, with a special focus on advancing neuroscience therapies. Our Wrexham site is a vital part of this mission, delivering cutting-edge solutions in a dynamic and collaborative environment. We are proud to be Great Place to Work certified and a Shingo Bronze Medallion holder, reflecting our commitment to excellence, innovation, and continuous improvement.
With a recent 24 million investment in the site and a further 86.4 million expansion underway, there has never been a more exciting time to join us. If you are passionate about making an impact and want to be part of a team that values growth, innovation, and excellence, then Ipsen could be where you thrive!
We are seeking an experienced and strategic Senior Manager, CMC Regulatory Strategy - Biologics to join our Global Regulatory Affairs team. In this role, you will lead the development and execution of global CMC regulatory strategies for an exciting new asset across all stages of development and lifecycle management. You will play a key role in ensuring regulatory compliance and accelerating product delivery to patients worldwide.
Key Responsibilities:

• Lead global CMC regulatory strategy for assigned biologics projects.
• Oversee preparation and submission of CMC sections for INDs, IMPDs, MAAs, and CTAs.
• Collaborate with cross-functional teams including Pharmaceutical Development, Technical Operations, and Regulatory Affairs.
• Ensure compliance with global regulatory requirements and anticipate emerging regulations.
• Represent Ipsen in regulatory interactions and industry forums.
• Mentor junior regulatory colleagues and contribute to continuous improvement initiatives.

Knowledge, Skills & Experience:

• Significant experience in CMC regulatory affairs. Experience with biologics/biotechnological products is preferred.
• Proven experience in global regulatory submissions and health authority interactions.
• Strong understanding of regulatory requirements in EU and US. Experience with international markets is preferred

If you're passionate about making a global impact in healthcare and thrive in a collaborative, fast-paced environment, we'd love to hear from you!
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IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.