Director Regulatory CMC

Associate Director / Director, Global Regulatory Affairs CMC About the Opportunity

A growing biopharmaceutical organization is seeking an experienced Regulatory Affairs CMC professional to lead global regulatory strategy and execution across development, registration, and lifecycle management activities for complex pharmaceutical products.

This individual will serve as a key strategic partner to cross-functional teams, providing regulatory CMC leadership throughout clinical development and commercialization. The role offers the opportunity to influence global regulatory strategy, support major submissions, and engage directly with international health authorities.

• Develop and execute global Regulatory CMC strategies for development-stage and commercial products.
• Lead CMC aspects of major regulatory submissions, including INDs, CTAs, NDAs, BLAs, MAAs, variations, and post-approval submissions.
• Provide strategic regulatory guidance to cross-functional teams across Pharmaceutical Development, Manufacturing, Quality, and Regulatory Affairs.
• Drive preparation and support for Health Authority interactions and regulatory meetings.
• Review and provide regulatory input on technical documentation, protocols, reports, change controls, investigations, and lifecycle management activities.
• Identify regulatory risks and develop mitigation strategies to support successful product development and commercialization.
• Ensure regulatory compliance with global CMC requirements and evolving regulatory expectations.
• Contribute to regulatory intelligence activities and apply insights to support program strategy.
• Mentor and support junior regulatory professionals while fostering collaboration across global teams.

• Advanced scientific degree (MS, PhD, PharmD, or equivalent) preferred.
• 10+ years of biopharmaceutical industry experience, including significant Regulatory Affairs CMC experience.
• Proven success leading CMC strategy and execution for global regulatory submissions across development and commercial programs.
• Strong understanding of global CMC regulatory requirements for biologics, pharmaceuticals, and/or combination products.
• Experience supporting interactions with FDA, EMA, and other international regulatory agencies.
• Demonstrated ability to influence cross-functional teams and operate effectively within a matrix environment.
• Excellent communication, leadership, and problem-solving skills.

• Visible leadership role with significant strategic impact.
• Opportunity to shape global regulatory strategy across multiple programs.
• Exposure to innovative therapies and complex regulatory challenges.
• Collaborative, science-driven environment with strong growth potential.