# Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP)

Hiring organization: [Biogen](https://career.thegoodapps.co/organizations/biogen)

Canonical page: https://career.thegoodapps.co/jobs/d8a16cc9-12d3-4aa7-bdf4-94cfdd182d9f

Listed on Biogen's own careers site. Applications go to them directly.

- Employment type: full time
- Seniority: Senior
- Location: Cambridge, MA
- Salary: 241000 – 332000 USD per year

## Summary

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._

## 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

Apply on Biogen's site: https://biibhr.wd3.myworkdayjobs.com/en-US/external/job/Cambridge-MA/Head-of-Regulatory-CMC---Biologics---Advanced-Therapy-Medicinal-Products--ATMP-_REQ23835-1