Senior Regulatory Cmc Drug-Device Combination Product Lead

Biogen; 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

About This Role:

As the Senior Regulatory CMC Device and Combination Product Lead, you will play a pivotal role in providing Device and Combination Product Regulatory expertise to support the development and implementation of global regulatory strategies.

This position is critical to ensure the clinical and commercial success of key assets, making it highly visible within the organization and across the company. You will collaborate with cross-functional teams, lead regulatory submissions, and contribute to the development of processes that advance business objectives. In this role, your work will directly impact the delivery of innovative treatments to patients worldwide, enabling Biogen to maintain its leadership in biotechnology.

What You'll Do:

• 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 representing 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 overall plans effectively to leadership and cross-functional teams.
• Author, review, and approve CMC submissions and responses to Health Authority questions in alignment with global regulatory strategies and timelines.
• Collaborate with cross-functional teams to prepare submissions and responses to Health Authority CMC questions for assigned projects and products.
• Monitor and communicate legislative and regulatory developments in relevant areas, ensuring stakeholders are informed of changes.
• Participate in regulatory intelligence activities and trade organization working groups to support corporate objectives.
• Develop and enhance regulatory processes and procedures to align with department goals and objectives.
• Build strong internal relationships with key functions and deliver effective presentations to internal audiences.

Who You Are:

You are a detail-oriented problem solver who thrives in a collaborative, fast-paced environment. You possess a strong ability to analyze complex regulatory requirements and communicate strategies effectively. You are passionate about advancing innovative medical devices and combination products while ensuring compliance and excellence in your work. You understand the importance of building relationships across teams and take pride in delivering results that drive organizational success.

Required Skills:

• Minimum of a bachelor's degree (BS) and at least 5 years of regulatory experience, ideally in the medical device, pharmaceutical, or biotechnology industries.
• In-depth understanding of how regulatory functions within a business environment and how Regulatory interfaces with multiple functional areas.
• Experience in Medical Device and/or Combination Product Regulatory Affairs in a similar or junior role.
• Understanding of the application of cGMP for Medical Devices and Combination Products.
• Awareness of applicable legislation, regulations, guidance, and standards related to medical devices and combination products.
• Strong analytical abilities and attention to detail.

Preferred Skills:

• Degree in Life/Health Sciences or Engineering.

Job Level: Management

Additional Information

The base compensation range for this role is: $111,000.00-$149,000.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. to learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.