Senior Regulatory CMC Drug-Device Combination Product Lead
BiogenRemote, USA · Remote · full time · Senior
$111,000 – $149,000
Listed on Biogen’s own careers site. You apply with them directly — we never stand between you and the employer.
What this role is
This role leads regulatory and CMC (Chemistry, Manufacturing, Controls) strategy for medical devices and combination products at a biotechnology company, working across teams to guide submissions and ensure compliance. It suits experienced regulatory professionals with device industry background who want to advance to a leadership position and directly influence the approval pathway for innovative treatments.
Our summary, not Biogen’s wording. The full posting is on their site.
What they ask for
Required
- Bachelor's degree
- 5+ years regulatory experience in medical device, pharmaceutical, or biotechnology
- Medical device and/or combination product regulatory affairs experience
- Understanding of cGMP for medical devices and combination products
- Knowledge of applicable legislation, regulations, guidance, and standards for medical devices and combination products
- Strong analytical abilities and attention to detail
Nice to have
- Degree in Life Sciences, Health Sciences, or Engineering