Senior Regulatory CMC Drug-Device Combination Product Lead

Job Title:

Senior Regulatory CMC Drug-Device Combination Product Lead

Job Location:

Remote, USA

Job Location Type:
Remote

Job Contract Type:
Full-time

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.

• 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.

• 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.

• Degree in Life/Health Sciences or Engineering.

The base compensation range for this role is: $-$. 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…