Director, Global Reg CMC for Combination Products and Medical Devices

Job Description

About This Role:

As the Director of Global Reg CMC for Combination Products and Medical Devices, you will take on a pivotal role within our Product Delivery Solutions team. Your expertise will guide end-to-end (E2E) CMC regulatory strategies and operations throughout the development and lifecycle management of our diverse and cutting-edge device portfolio. In this role, you'll manage crucial responsibilities including global regulatory oversight, ensuring compliance and quality of submissions, and maintaining continuous product supply. You'll bring invaluable leadership, mentoring a dynamic team and fostering cross-functional and cross-regional collaboration. Reporting to the VP / Head of Product Delivery Solutions, you will be an integral part of both the Product Delivery Solutions Leadership Team and the Global RegCMC Leadership, contributing significantly to our business needs and most importantly, patient care.

The ideal candidate will work in a hybrid setting in one of our offices located in either Cambridge, MA or RTP, NC (remote may also be considered).

What You’ll Do

• Provide strategic direction for the development of innovative regulatory CMC device and combination product strategies, ensuring alignment with business objectives and patient supply continuity.
• Lead the establishment of regulatory strategies for devices and combination products, ensuring compliance with international standards.
• Guarantee the quality, content, format, and timely submission of regulatory CMC submissions, securing approvals in international markets.
• Build, develop and lead a team of individuals with device and combination product regulatory experience, striving for cross-functional collaboration
• Collaborate with internal stakeholders to ensure dossier compliance and manage regulatory CMC submissions and variations for Drug Device Combinations/Integral products.
• Offer regulatory CMC support for Quality systems including change control, deviation management, and inspection management.
• Build and maintain relationships with various Biogen functions, facilitating a comprehensive understanding of end-to-end processes for continuous improvement.
• Provide leadership to Global and Regional Regulatory Leads and Asset Teams, managing Health Authority interactions and critical regulatory issues.
• Interpret global regulations and guidelines, applying advanced knowledge to navigate worldwide health authority requirements (US/CAN, EEA, AP, MEA, LA).
• Engage in smart risk-taking, utilizing new regulatory approaches and paradigms to enhance patient value and product differentiation.
• Actively participate in external industry meetings, conferences, and forums, influencing policy and driving Biogen's stance on device portfolio management.
• Develop and maintain relationships with Health Authorities and trade association representatives, leveraging these connections to reflect Biogen's positions.
• Generate meaningful metrics and reports to track key regulatory CMC performance indicators.
• Standardize processes, share best practices, and outsource activities to create efficiencies within the department.
• Provide valuable input to the Global Regulatory CMC Leadership Team and contribute to the development of strategic roadmaps.
• Interact ethically with a broad range of international, cross-functional departments and industry peers at all levels, maintaining a customer-focused approach.

Who You Are:

You are a visionary leader with a global mindset and a track record of excellence in the regulatory CMC space. Your communication skills are exceptional, allowing you to negotiate and interact seamlessly with teams and stakeholders across the globe. You are adept at mentoring, developing, and empowering your team to achieve greatness. With your extensive industry experience, you bring a deep understanding of medical devices and combination products and are driven by the opportunity to impact patient care through strategic regulatory oversight. You embody the qualities of a forward-thinker who embraces challenges and thrives in a dynamic, collaborative environment.

Required Skills:

• Bachelor’s degree with a minimum of 12 years of industry experience in Medical Device and Combination Products Regulatory Affairs. Experience should include:
  • A minimum of 8 years of experience leading Global Regulatory Affairs teams
  • A minimum of 8 years of international CMC regulatory experience.

• Prior direct experience in regulatory submission preparation.
• Extensive experience with international health authority interactions.
• Advanced knowledge of global regulations, guidelines, and expectations for product licensure and marketin