# Senior Regulatory CMC Drug-Device Combination Product Lead

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

Canonical page: https://career.thegoodapps.co/jobs/e5e507d5-ddd8-4e8f-807b-6e0a6f604126

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

- Employment type: full time
- Seniority: Senior
- Location: Remote, USA
- Remote: yes
- Salary: 111000 – 149000 USD per year

## Summary

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._

## 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

Apply on Biogen's site: https://biibhr.wd3.myworkdayjobs.com/en-US/external/job/Remote-USA/Senior-Regulatory-CMC-Drug-Device-Combinations-Lead_REQ23895-1