Executive Director, Regulatory CMC

Role Summary

The Executive Director, Regulatory CMC provides strategic leadership for global CMC regulatory activities across all stages of drug development and life cycle management. This role serves as a liaison to health authorities, driving regulatory strategies and high-quality submissions while ensuring compliance with FDA, EMA, and ICH guidelines. It requires deep expertise in small molecule development, cross-functional collaboration, and the ability to influence policies and processes in a fast-paced environment. The candidate will combine strategic vision with hands-on leadership to accelerate development and commercialization.

Responsibilities

• Provide overall regulatory CMC strategy for drug development programs and life cycle management, ensuring alignment with corporate objectives and timelines.
• Serve as a spokesperson and trusted liaison with FDA and other health authorities, leading negotiations and presenting CMC positions effectively.
• Develop de-risking strategies for CMC development, assess change controls, and identify opportunities to accelerate development in a dynamic environment.
• Lead creation and execution of comprehensive CMC development plans for new products, ensuring integration with Technical Operations and external partners.
• Partner with supply chain, clinical operations, and manufacturing teams to ensure readiness and compliance for clinical and commercial supply.
• Oversee preparation and quality of all CMC regulatory submissions (INDs, BLAs, MAAs, DMFs, IMPDs, amendments, annual reports), providing strategic direction and ensuring global compliance.
• Drive the development and implementation of departmental policies, SOPs, and best practices to support scalability and operational excellence in a growing organization.
• Interpret and communicate regulatory CMC requirements and expectations to internal teams and external partners to ensure program objectives are met.
• Contribute to corporate initiatives aimed at improving regulatory standards, systems, and processes across the organization.

Qualifications

• Master’s degree in chemistry, pharmaceutical sciences, or a related scientific field (PharmD or PhD preferred).
• Minimum 15 years in the pharmaceutical industry, including at least 7 years in Regulatory CMC.
• Demonstrated experience across early-stage, late-stage development, and life cycle management for small molecule products.
• Comprehensive understanding of FDA, EMA, and ICH CMC guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP).
• Proven experience preparing and submitting CMC regulatory documents (e.g., INDs, IMPDs, CTAs, BLAs, MAAs) and leading successful interactions with health authorities such as FDA and EMA.
• Track record of developing and executing CMC regulatory strategies, balancing near-term objectives with long-term goals.
• Strong leadership skills with the ability to work effectively in a matrixed environment; excellent verbal and written communication skills to articulate regulatory viewpoints to diverse audiences.
• Ability to thrive in a fast-paced, collaborative environment and comfortable with both strategic planning and hands-on execution.

Additional Requirements

• Work Location: Remote in the United States, with occasional travel.