Director, Global CMC Regulatory

Minimum of 15 years of experience in pharmaceutical / biotech drug development, including at least 5 years of hands-on global CMC regulatory affairs experience.

Deep expertise in CMC development for new chemical entities (NCEs) and small molecules, with proven ability to manage complex technical content.

Extensive experience leading global CMC regulatory strategy and global marketing approval applications across the US, Canada, Europe, UK, APAC, and LATAM regions.

Strong knowledge of US and international GMP regulations, current industry practices, with a demonstrated ability to interpret and apply requirements across the product lifecycle.

Proven track record of building and maintaining productive relationships with global Health Authorities, including direct interactions with the FDA and other regulatory bodies.

Experience supporting global commercial labeling implementation and lifecycle updates, with strong knowledge of global labeling requirements and artwork development/approval processes, including coordination of CMC-related labeling impacts across regions.

The Director, Global CMC Regulatory is a strategic leadership role responsible for developing, driving, and executing global commercial CMC regulatory strategies to secure and maintain marketing approvals for RevMed’s product portfolio worldwide.

This position provides leadership for commercial-stage CMC regulatory activities, including original marketing applications, global expansions, and post-approval lifecycle management.

This role requires deep expertise in global commercial CMC regulatory frameworks, strong cross-functional leadership, and the ability to proactively anticipate regulatory risks while enabling business objectives.

Develop and lead execution of effective global CMC regulatory strategies to support initial marketing approvals and lifecycle management of RevMed's product portfolio.

Oversee the preparation and submission of high-quality CMC dossiers for global marketing authorization applications and post-approval supplements/variations.

Manage/lead interactions with Health Authorities as needed.