Senior Regulatory CMC Device Lead

As the Senior Regulatory CMC Device Lead you will play a pivotal role in providing Regulatory CMC expertise to support the development and implementation of global regulatory strategies for combination products and medical devices. Your focus will be on singleentity combination product development such as prefilled syringes autoinjectors and in vitro diagnostics.

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 crossfunctional 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.

This is a hybrid role that can be based at our offices in either Research Triangle Park NC or Cambridge MA.

What Youll Do:

• Represent the Regulatory CMC Device function on crossfunctional 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 crossfunctional work streams.
• Develop and execute regulatory strategies for medical devices and combination products including new registration submissions and postapproval applications.
• Communicate CMC regulatory strategies risks and overall plans effectively to leadership and crossfunctional teams.
• Author review and approve CMC submissions and responses to Health Authority questions in alignment with global regulatory strategies and timelines.
• Collaborate with crossfunctional 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 detailoriented problem solver who thrives in a collaborative fastpaced 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 Bachelors Degree (BS) and 5 years of regulatory experience ideally in the pharmaceutical or biotechnology industry.
• Indepth understanding of 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.

Additional Information :

The base salary range for this position is $114000$152000. 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 longterm 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 wellbeing; including but not limited to:

• Medical Dental Vision & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short and LongTerm Disability insurance
• A minimum of 15 days of paid vacation and an additional endofyear shutdown time off (Dec 26Dec 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 $10000 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 midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging 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. Read on to learn more about our DE&I efforts.

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 EVerify Employer in the United States.