Vice President, Global CMC Regulatory

Responsibilities

• Global CMC Regulatory Strategy
  • Develop and execute global CMC regulatory strategies in alignment with product development plans for clinical and commercial programs / marketed products.
  • Provide strategic CMC regulatory leadership to support global filings, approvals, and post-approval lifecycle management.
  • Proactively identify and manage CMC regulatory risks, anticipate challenges and develop mitigation strategies to support business objectives and ensure global alignment and compliance.
• Health Authority Engagement
  • Serve as the primary CMC regulatory interface with global health authorities, including FDA, EMA, EU National Competent Authorities, and PMDA.
  • Lead and support CMC-related regulatory meetings, scientific advice, and responses to health authority questions.
• Regulatory Submissions & Lifecycle Management
  • Oversee the preparation, review, and submission of high-quality CMC sections for NDAs, MAAs, J-NDAs, and global post-approval variations.
  • Ensure consistency, compliance, and scientific rigor across global CMC regulatory filings.
  • Provide strategic oversight for post-approval changes, including site changes, process improvements, and supply chain optimization.
  • Interpret and apply evolving CMC regulatory requirements and guidance globally.
• Cross-Functional Collaboration
  • Partner closely with Drug Substance, Drug Product, Analytical Development and QC, Manufacturing, Supply Chain, Quality, and Program Management to align regulatory strategy with technical and operational plans.
  • Act as a regulatory subject matter expert for tech transfer, global site registration, comparability protocols and control strategy development.

Qualifications

• Advanced degree (PhD, PharmD, or MS) in Chemistry, Pharmaceutical Sciences or related scientific discipline.
• Minimum of 18 years of experience in the biotech/pharmaceutical industry, with at least 10 years in CMC regulatory affairs and global submission experience.
• Demonstrated success leading global CMC regulatory strategies for small-molecule products.
• Proven success scaling CMC regulatory function in a public, late-stage biotech/pharma company.
• Deep understanding of global regulatory frameworks and guidelines (FDA, ICH, EMA, PMDA, NMPA, etc.).
• Strong leadership and collaboration skills with a demonstrated ability to work cross-functionally and influence stakeholders at all levels.
• Strong written and verbal communication skills, with the ability to clearly articulate regulatory strategy and risk.
• Ability to thrive in a fast-paced, matrixed, and science-driven environment.