Regulatory CMC Lead, Devices & Combination Products

Biogen; United States; Remote; USD 111,000 - 149,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Fitness reimbursement

Disability Insurance

Paid vacation

Holidays

Sick time

Parental leave

401(k) matching

Employee Stock Purchase Plan

Tuition reimbursement

ERG participation

Job summary

Biogen in the United States is seeking a Senior Regulatory CMC Device and Combination Product Lead to guide global regulatory strategies for devices and combination products. You will lead submissions and collaborate with cross-functional teams to advance key assets.

The role requires a BS and 5+ years in regulatory affairs for medical devices or biotech, with expertise in cGMP and Health Authority interactions, and offers a comprehensive benefits package and performance incentives.

Qualifications

• BS degree required with 5+ years regulatory experience in medical devices, pharmaceuticals, or biotech.
• Strong understanding of regulatory interfaces across functions and business units.
• Experience in Medical Device and/or Combination Product Regulatory Affairs.
• Knowledge of cGMP for Medical Devices and Combination Products.
• Awareness of applicable regulations, guidance, and standards.

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, such as cross-functional work streams.
• Develop and execute regulatory strategies for medical devices and combination products, including new registrations and post-approval modifications.
• Communicate CMC regulatory strategies, risks, and plans to leadership and cross-functional teams.
• Prepare, review, and approve CMC submissions and responses to Health Authority questions in alignment with global strategies and timelines.
• Collaborate with teams to prepare submissions and responses to Health Authority CMC questions for assigned projects and products.
• Monitor regulatory developments and inform stakeholders of changes.
• Participate in regulatory intelligence activities and trade organization groups.

Skills

Regulatory affairs

Cross-functional collaboration

Regulatory strategy

cGMP knowledge

Regulatory submissions

Analytical thinking

Education

Bachelor's degree (BS)

Job description

Biogen in the United States is seeking a Senior Regulatory CMC Device and Combination Product Lead to guide global regulatory strategies for devices and combination products. You will lead submissions and collaborate with cross-functional teams to advance key assets.

The role requires a BS and 5+ years in regulatory affairs for medical devices or biotech, with expertise in cGMP and Health Authority interactions, and offers a comprehensive benefits package and performance incentives.