Associate Director, GRA CMC Development

Role Overview

A seasoned regulatory professional with the ability to independently manage and lead CMC (Chemistry, Manufacturing, and Controls) regulatory activities for assigned development programs and clinical projects, including cell and gene therapies where applicable. This role acts as the acknowledged RA CMC authority for a designated product type, region, or country, providing technical and regulatory expertise that supports global development efforts. The position ensures compliant, high-quality CMC regulatory outputs and anticipates potential risks, under the guidance of the RA CMC Development Team Lead.

Key Responsibilities

• Serve as the lead RA CMC expert and regulatory contact for designated development programs, overseeing all CMC regulatory deliverables from start to finish.
• Provide authoritative guidance on CMC regulatory requirements for a specific product type or region, interpreting regional expectations accurately.
• Independently create and implement CMC regulatory strategies for assigned programs, ensuring alignment with global development plans and local regulatory requirements.
• Lead and collaborate with cross-functional teams—including CMC, manufacturing, quality, and supply chain—to integrate regulatory considerations into development plans.
• Manage the preparation, review, and coordination of CMC sections of regulatory submissions, such as INDs/IMPDs, CTA/CTNs, amendments, and other project-specific filings.
• Ensure CMC documentation and regulatory responses for assigned programs are of high quality, consistent, and delivered on time.
• Support drafting CMC sections for initial global marketing applications, ensuring regional compliance.
• Act as the regional RA CMC lead during Health Authority interactions, including developing positions, briefing materials, and regulatory responses.
• Represent CMC in meetings with regulatory agencies, including scientific advice, pre-IND, end-of-phase, and pre-submission discussions as required.
• Identify CMC regulatory risks, gaps, and opportunities within programs or regions, proposing mitigation strategies and escalating when necessary.
• Oversee CMC regulatory activities performed by external partners, CMOs, or vendors, ensuring compliance with regional regulatory standards.
• Maintain up-to-date knowledge of regional CMC regulations and industry developments, advising global teams on potential impacts.
• Contribute to the creation and improvement of SOPs, work instructions, and best practices related to CMC regulatory operations.
• Provide leadership and support for GxP inspections or audits related to CMC development and manufacturing, including regional inspections where applicable.

Required Qualifications

• Degree in life sciences or a related field, with experience in pharmaceutical regulatory affairs.
• Proven experience in RA CMC for development-stage biologics, including familiarity with CMC requirements from early to late clinical stages.
• Experience leading global CMC regulatory strategies, coordinating cross-functional input, and ensuring alignment with program objectives.
• Experience preparing and managing CMC regulatory submissions, including INDs/IMPDs, CTA/CTNs, amendments, and responses to regulatory queries.
• Direct experience interacting with regulatory authorities (e.g., FDA, EMA, MHRA, national agencies) on CMC topics, including preparing for and participating in scientific advice or similar meetings.