[Hiring] Senior Regulatory CMC Drug-Device Combination Product Lead @Biogen

Role Description

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.

• 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.

Qualifications

• 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.

Requirements

• Degree in Life/Health Sciences or Engineering (preferred).

Benefits

• 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.