Director, Global CMC Regulatory

The Opportunity:

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.

Responsibilities:

• 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.

• Assess the global regulatory implications of proposed CMC changes and provide proactive, risk-based guidance to optimize implementation and maintain compliance.

• Interpret and apply global CMC regulatory guidance (FDA, EMA, ICH, PMDA, NMPA, MHRA, etc.) to ensure compliant and efficient regulatory pathways.

• Anticipate regulatory risks and proactively develop mitigation strategies aligned with commercial timelines.

• Partner with Regulatory Affairs, technical SMEs, and CROs to ensure alignment of global submission strategies while addressing region-specific CMC requirements and serve as the CMC regulatory representative on global commercial teams to provide guidance that enables efficient global execution.

• Provide strategic leadership, mentorship, and technical guidance to junior team members to foster professional development and team performance.

Required Skills, Experience and Education:

• Bachelor’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related scientific discipline.

• 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.

• Strong project and team leadership capabilities, with the ability to prioritize effectively, manage multiple complex programs, and foster cross-functional collaboration.

• Effective written and verbal communication skills and interpersonal skills.

• A collaborative, high-energy team player who thrives in a fast-paced, dynamic environment and embraces innovation and continuous improvement.

Preferred Skills:

• Advanced degree (MS or Ph.D) in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field.

• 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.

• Prior experience in oncology product commercialization is a plus. 

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