Senior Regulatory CMC Lead — Medical Devices & Combo Products

Mygwork; Oregon; On-site; USD 111,000 - 149,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) with match

Tuition reimbursement

Equity incentive opportunities

Employee stock purchase plan

Paid vacation

Paid holidays

Parental leave

Job summary

Biogen is seeking a Senior Regulatory CMC Device and Combination Product Lead to guide regulatory strategy for devices and combo products across global programs. You will collaborate with cross-functional teams, author submissions, and drive regulatory intelligence to ensure timely approvals and sustained product lifecycle support.

The role emphasizes leadership in regulatory strategy, effective communication with senior stakeholders, and shaping processes to advance Biogen's innovative

Qualifications

• Minimum of a bachelor's degree and at least 5 years of regulatory experience in medical devices/pharma/biotech.
• Understanding of regulatory interfaces across functional areas.
• Experience in Medical Device and/or Combination Product Regulatory Affairs.
• Knowledge of cGMP for Medical Devices and Combination Products.
• Awareness of applicable legislation, regulations, guidance, and standards.

Responsibilities

• Represent Regulatory CMC on cross-functional teams and guide regulation for devices and combination products.
• Author and coordinate regulatory documentation and submissions.
• Lead or assist in project assignments within cross-functional streams.
• Develop and execute regulatory strategies for medical devices and combo products, including new registrations and post-approval submissions.
• Communicate CMC strategies, risks, and plans to leadership and teams.
• Author, review, and approve CMC submissions and responses to Health Authority questions.
• Collaborate with teams to prepare submissions and responses to Health Authority CMC questions.
• Monitor regulatory developments and inform stakeholders of changes.
• Participate in regulatory intelligence activities and trade groups.
• Develop and enhance regulatory processes and procedures.
• Build internal relationships and present to internal audiences.

Skills

Regulatory experience

Regulatory strategy development

Cross-functional collaboration

Regulatory submissions

Education

Bachelor's degree (BS)

Job description

Biogen is seeking a Senior Regulatory CMC Device and Combination Product Lead to guide regulatory strategy for devices and combo products across global programs. You will collaborate with cross-functional teams, author submissions, and drive regulatory intelligence to ensure timely approvals and sustained product lifecycle support.

The role emphasizes leadership in regulatory strategy, effective communication with senior stakeholders, and shaping processes to advance Biogen's innovative