The Opportunity:

We are seeking an accomplished, strategic and execution-oriented leaders, Vice President, Global CMC Regulatory, reporting to SVP of Pharmaceutical Development and Manufacturing (PDM) Regulatory, to lead our global chemistry, manufacturing, and controls (CMC) regulatory strategy and execution across all development programs and commercial assets.  This leader will drive regulatory strategy development, lead regulatory interactions, and provide expertise throughout the product lifecycle, from early development to post-approval variations ensuring the timely submission and approval of high-quality CMC regulatory filings to support our company’s pipeline and global growth. 

The successful candidate will serve as a senior leadership role within Pharmaceutical Development and Manufacturing (PDM) organization, overseeing CMC regulatory activities and ensuring alignment with health authority expectations globally (FDA, EMA, PMDA, NMPA, etc.).    The role requires expertise in small molecule pharmaceutical development and manufacturing, an understanding of the oncology development lifecycle, and the ability to thrive in a dynamic, fast-paced environment.

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.

Team Development & Leadership

• Build, mentor, and lead a high-performing global CMC regulatory team, fostering accountability, development, and innovation.

• Manage external regulatory consultants and regional partners to ensure consistent global execution and local expertise.

Required Skills, Experience and Education:

• 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.

Preferred Skills:

• Experience with oncology development programs and familiarity with accelerated or expedited pathways.

• Experience with Japan-specific CMC regulatory requirements (e.g., consultations, GQP/GMP compliance, J-NDA format).

• Exposure to lifecycle management activities including global variations, site changes, and supply chain adaptations. 

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