Join to apply for the Senior Manager, CMC Regulatory Strategy role at Ipsen.
At Ipsen, we are committed to improving the lives of patients, with a focus on neuroscience therapies. Our Wrexham site is a vital part of this mission, delivering innovative solutions in a collaborative environment. We are proud to be Great Place to Work certified and a Shingo Bronze Medallion holder, reflecting our dedication to excellence and continuous improvement.
With recent investments and ongoing expansion, now is an exciting time to join us. If you are passionate about making an impact and value growth, innovation, and excellence, Ipsen could be the place for you.
We are seeking an experienced Senior Manager, CMC Regulatory Strategy – Biologics to lead our global regulatory efforts. You will develop and execute CMC strategies for new assets across all development stages, ensuring compliance and facilitating product delivery worldwide.
Key Responsibilities
1. Lead global CMC regulatory strategy for biologics projects.
2. Oversee preparation and submission of CMC sections for INDs, IMPDs, MAAs, and CTAs.
3. Collaborate with cross-functional teams including Development, Operations, and Regulatory Affairs.
4. Ensure compliance with global regulations and stay ahead of emerging requirements.
5. Represent Ipsen in regulatory interactions and industry forums.
6. Mentor junior staff and contribute to continuous improvement initiatives.
Knowledge, Skills & Experience
1. Extensive experience in CMC regulatory affairs, with biologics/biotech preferred.
2. Proven track record in regulatory submissions and authority interactions.
3. Strong understanding of EU and US regulations; international experience is a plus.
If you are passionate about impacting healthcare globally and thrive in a fast-paced, collaborative environment, we want to hear from you!
Additional Details
* Employment type: Full-time
* Job function: Legal
* Industry: Pharmaceutical Manufacturing
This job posting is active; no indication of expiration is present.
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