Senior Director, Regulatory Combination Product

Role Summary

As the Senior Director, Regulatory Combination Product, you will play a critical role in defining and driving regulatory compliance of biologics-device combination products across their development lifecycles. You will collaborate in a dynamic environment with device development, device quality, and CMC Team SMEs to support the development and commercialization of therapeutic products for rare diseases. APFS or Auto-Injector experience specifically is highly preferred. The role is open to remote work.

Responsibilities

• Develop comprehensive strategies that address both biologic and device components and align with corporate goals and regulatory expectations.
• Provide guidance for plans and protocols for compatibility studies, design verification studies and functional stability studies, and contribute to the design of human factor studies and usability testing.
• Interpret regulatory regulations, standards, directives, guidelines and advise Development, Technical Operations, and Quality on their applicability to and impact on product development projects.
• Deliver strategic input to Design Control processes and documentation, ensuring alignment with health authority and notified body requirements and global technical standards. Review DHF documentation from a regulatory perspective.
• Design and execute effective submission strategies for device-related dossier components (INDs/CTAs, marketing applications, and post-approval changes) in collaboration with SMEs.
• Conduct precedent research to ensure creation of state-of-the-art studies.
• Influence cross-functional decision-making without direct authority, operating effectively in a matrixed environment.
• Perform assessment of change controls to identify and mitigate regulatory risks.
• Lead interactions with health authorities and notified bodies.
• Help manage device-related regulatory information in company systems.
• Support for other Regulatory CMC activities.

Qualifications

• Experience as regulatory lead in pharmaceutical, biotechnology, or medical device industries, specifically with combination product filings.
• Strong knowledge of and broad experience with regulations, standards, directives, guidelines and requirements related to the use of combination products in global clinical studies and commercial registration.
• Proven track record in late-stage development of combination products.
• In-depth understanding of ISO and ASTM standards relevant to combination products.
• Solid understanding of current industry trends and regulatory expectations associated with combination products.
• Good understanding of ICH guidelines and GMP requirements for development and manufacturing of biologics.
• Strategic acumen, collaboration, influencing skills, and communication skills are important for success.

Education

• A bachelor's degree in a scientific/engineering discipline