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Salary: USD 143,000 - 233,000 / annual
Relay Therapeutics, a clinical-stage precision medicines company, seeks an Associate Director/Director of CMC Regulatory to lead Chemistry, Manufacturing and Control (CMC) regulatory strategy and execution within the Pharmaceutical Development team.
You will work with minimal supervision to develop and lead regulatory CMC strategies for investigational, registration, and post-approval programs. Key responsibilities include:
• Developing and executing CMC global submission plans and timelines aligned with project goals
• Applying deep knowledge of global regulatory CMC requirements (FDA, EMA, ICH) to enhance probability of regulatory success and compliance
• Leading coordination of responses to CMC questions and RFIs from regulatory authorities
• Independently defining CMC content (data and documentation) requirements for regulatory submissions and reviewing conformance
• Acting as regulatory CMC liaison between CMC, Pharmaceutical Development, Regulatory Affairs, and Program Management
• Leading CMC-regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
• Proactively communicating CMC regulatory strategies, key issues, and risks to cross-functional teams and management
• Staying current with regulatory guidance and technical/scientific developments relevant to assigned programs
You will manage multiple projects with competing priorities, exercise strong judgment in escalating issues, and work collaboratively across internal and external teams.
REQUIREMENTS:
• Bachelor's or advanced degree in Pharmaceutical Sciences, Chemistry, or related field
• Minimum 8–10+ years of relevant experience in regulatory-CMC and/or CMC function (analytical, formulation, process development, QA, QC) in biotech/pharmaceutical industry, with focus on small molecules and oral solid products (tablets, capsules)
• Experience authoring, reviewing, and providing CMC content for IND, IMPD, NDA, and MAA submissions
• Knowledge of eCTD Modules and Quality Overall Summary (QOS) requirements
• Experience managing submissions in RIM Veeva or equivalent; document formatting compliant with eCTD templates
• Strong background in clinical (IND/IMPD) and/or commercial (NDA/MAA) submissions
• In-depth knowledge of global CMC regulatory requirements and guidelines
• Excellent technical writing and document review skills
• Strong organizational skills, multi-tasking ability, problem-solving, and ability to work under pressure
• Strategic thinking with forward-looking perspective and strong communication and collaboration skills
