Exec Director, Regulatory Affairs-Combination Products & Devices

Role Summary

Exec Director, Regulatory Affairs-Combination Products & Devices responsible for defining and driving global regulatory strategies for combination products and devices, ensuring alignment with corporate goals and regulatory expectations. Lead regulatory excellence across global markets, influence cross-functional decision-making in a matrixed environment, and provide strategic direction for late-stage development programs and regulatory submissions.

• Strategic Leadership & Vision:
  Define and drive global regulatory strategies for combination products, champion regulatory innovation, and guide development and regulatory paths for combination products and devices.
• Global Regulatory Excellence:
  Lead the development of global CMC regulatory initiatives for combination products and devices, ensuring conformance and compliance across markets.
• Enterprise Collaboration & Influence:
  Build collaborative relationships across Quality, Manufacturing, Technical Development, Clinical Development, and Supply Chain; influence cross-functional regulatory planning in a matrixed environment.
• Program Oversight & Governance:
  Provide strategic direction for late-stage development programs, guide packaging and development teams, and lead major regulatory applications and lifecycle management strategies.
• 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:
  Contribute to Design Control processes and documentation, align with FDA 21 CFR Part 4 and global standards; support design history files, human factors studies, and process characterization.
• Leadership & Culture:
  Model company values and foster a culture of integrity, excellence, and continuous improvement within the global CMC RA organization.

• 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, Pharm
  
  D, or MD.
• Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.).
• Experience with leading NDA/BLA submission and approvals including global Health Authority Interactions.
• Application of sound and accurate judgment to make timely decisions.
• Demonstrated success in leading complex groups to support operational goals and contribute to the development of global regulatory initiatives.
• Demonstrated organizational leadership skills at both functional and enterprise levels.
• Excellent strategic acumen, collaboration, and communication skills are required.
• Experience supporting multiple regulatory filings including IND/IDE and NDA/BLA and supporting product-related inspections for 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 the successful development and commercialization of device technologies, innovation, and championing business practice improvements.
• Experience leading major initiatives to improve organizational capabilities.
• Demonstrated strategic thinking and influencing skills internally and externally.
• Sound working knowledge of global regulatory requirements for Combination Products/ Devices.
• Excellent leadership, collaboration and communication skills, as well as the proven ability to drive innovation and influence organization change.
• Solid understanding of current industry trends and regulatory expectations associated with QbD, comparability evaluation, scale up, and method and process validation.

• BA/BS or higher in a scientific discipline; advanced degree (MA/MS, PhD, Pharm
  
  D, MD) preferred.