Senior Regulatory CMC Drug-Device Combination Product Lead
Biogen
August 14, 2026
Remote friendly (United States)
United States
Corporate Functions
Responsibilities
- Represent the Regulatory CMC Device function on cross-functional teams and provide regulatory guidance for combination products and medical devices.
- Author and coordinate regulatory documentation and submissions while ensuring compliance with applicable regulations.
- Lead or assist in project assignments supporting business needs; represent Regulatory CMC in cross-functional work streams.
- Develop and execute regulatory strategies for medical devices and combination products, including new registration submissions and post-approval applications.
- Communicate CMC regulatory strategies, risks, and plans to leadership and cross-functional teams.
- Author, review, and approve CMC submissions and Health Authority responses in alignment with global regulatory strategies and timelines.
- Collaborate to prepare submissions and responses to Health Authority CMC questions for assigned projects/products.
- Monitor and communicate legislative and regulatory developments; participate in regulatory intelligence and trade organization working groups.
- Develop and enhance regulatory processes and procedures; build internal relationships and deliver presentations.
Qualifications
- Bachelor’s degree (BS) and at least 5 years of regulatory experience (medical device, pharmaceutical, or biotechnology preferred).
Required Skills
- Strong understanding of regulatory functions in a business environment and Regulatory interface across functional areas.
- Experience in Medical Device and/or Combination Product Regulatory Affairs.
- Understanding of cGMP for Medical Devices and Combination Products.
- Awareness of applicable legislation, regulations, guidance, and standards.
- Strong analytical abilities and attention to detail.
Preferred Skills
- Degree in Life/Health Sciences or Engineering.
Benefits/Compensation (if applicable)
- Base compensation range: $111,000.00–$149,000.00.
- Regular employees may receive short- and long-term incentives (cash bonus and equity opportunities).
- Represent the Regulatory CMC Device function on cross-functional teams and provide regulatory guidance for combination products and medical devices.
- Author and coordinate regulatory documentation and submissions while ensuring compliance with applicable regulations.
- Lead or assist in project assignments supporting business needs; represent Regulatory CMC in cross-functional work streams.
- Develop and execute regulatory strategies for medical devices and combination products, including new registration submissions and post-approval applications.
- Communicate CMC regulatory strategies, risks, and plans to leadership and cross-functional teams.
- Author, review, and approve CMC submissions and Health Authority responses in alignment with global regulatory strategies and timelines.
- Collaborate to prepare submissions and responses to Health Authority CMC questions for assigned projects/products.
- Monitor and communicate legislative and regulatory developments; participate in regulatory intelligence and trade organization working groups.
- Develop and enhance regulatory processes and procedures; build internal relationships and deliver presentations.
Qualifications
- Bachelor’s degree (BS) and at least 5 years of regulatory experience (medical device, pharmaceutical, or biotechnology preferred).
Required Skills
- Strong understanding of regulatory functions in a business environment and Regulatory interface across functional areas.
- Experience in Medical Device and/or Combination Product Regulatory Affairs.
- Understanding of cGMP for Medical Devices and Combination Products.
- Awareness of applicable legislation, regulations, guidance, and standards.
- Strong analytical abilities and attention to detail.
Preferred Skills
- Degree in Life/Health Sciences or Engineering.
Benefits/Compensation (if applicable)
- Base compensation range: $111,000.00–$149,000.00.
- Regular employees may receive short- and long-term incentives (cash bonus and equity opportunities).