Exec Director, Regulatory Affairs-Combination Products & Devices

Role Summary

Exec Director, Regulatory Affairs-Combination Products & Devices defines and drives global regulatory strategies for combination products, ensuring alignment with corporate goals and regulatory expectations. Leads regulatory excellence and oversees late-stage development programs, guiding cross-functional teams to integrate regulatory path planning across devices and combination products. Fosters enterprise collaboration and governance to influence regulatory planning and ensure readiness for global commercialization.

Responsibilities

• Strategic Leadership & Vision: Define and drive global regulatory strategies for combination products, champion regulatory innovation to accelerate development and approval timelines, and provide guidance to PDM Teams and Device Teams to align development and regulatory paths.
• Global Regulatory Excellence: Lead global CMC regulatory initiatives for combination products and devices, ensuring regulatory conformance and consistency across markets and compliance with evolving health authority requirements.
• Enterprise Collaboration & Influence: Cultivate collaborative relationships across Quality, Manufacturing, Technical Development, Clinical Development, and Supply Chain; influence cross-functional decision-making in a matrixed environment.
• Program Oversight & Governance: Provide strategic direction for late-stage development programs, guide combination and packaging development teams, lead major regulatory applications and lifecycle management strategies, and include early and late-stage programs in scope.
• Regulatory Operations & Submissions: Oversee drafting, review, and approval of CMC sections for regulatory filings; lead agency interactions, inspections, and regulatory responses; ensure readiness for global commercialization.
• Design Control & Technical Strategy: Provide strategic input to Design Control processes and documentation, ensure alignment with global standards, and contribute to design history files, human factors studies, and process characterization.
• Leadership & Culture: Model core values and leadership commitments, fostering integrity, excellence, and continuous improvement within the global CMC RA organization.

Qualifications

• A scientific degree with directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD.
• Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums on external policy topics (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.).
• Experience leading NDA/BLA submissions and approvals including global Health Authority interactions.
• Judgment to make timely decisions and ability to lead complex groups to support global regulatory initiatives.
• Demonstrated organizational leadership at functional and enterprise levels; excellent strategic acumen, collaboration, and communication skills.
• Experience supporting multiple regulatory filings including IND/IDE and NDA/BLA and inspections by US and foreign regulatory agencies.
• In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of small molecules and biologics.
• Proven track record in development and commercialization of device technologies and in driving business practice improvements.
• Experience leading major initiatives to improve organizational capabilities and demonstrated strategic thinking and influencing skills.
• Working knowledge of global regulatory requirements for Combination Products/Devices; ability to drive innovation and organizational change.
• Solid understanding of trends and regulatory expectations related to QbD, comparability evaluation, scale-up, and method and process validation.