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 Job Seniority Level: 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 s