Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP)
BiogenCambridge, MA · full time · Senior
$241,000 – $332,000
Listed on Biogen’s own careers site. You apply with them directly — we never stand between you and the employer.
What this role is
Lead regulatory strategy and CMC submissions for Biogen's biologics and advanced therapy pipeline, overseeing a team that manages global approvals and manufacturing compliance. This role suits experienced regulatory leaders with deep biologics expertise who thrive in cross-functional collaboration and can navigate complex health authority interactions.
Our summary, not Biogen’s wording. The full posting is on their site.
What they ask for
Required
- Advanced degree or PhD in Life Sciences, Pharmacy, Medicines, or related field
- Minimum 15 years regulatory agency or pharmaceutical industry experience
- Significant leadership experience in regulatory sciences
- Proven track record of global regulatory submissions and approvals for biologics and/or ATMPs
- Understanding of international regulations and major regulatory agency processes
- Strong cross-functional collaboration and negotiation skills
- Experience managing global development and manufacturing networks
Nice to have
- Active engagement in major industry associations, conferences and forums