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Iambic Therapeutics, a clinical-stage biotech company founded in 2020 and based in San Diego, is seeking an Associate Director or Director of Regulatory Affairs focused on Chemistry, Manufacturing and Controls (CMC). This role will lead global CMC regulatory strategy and execution across the company's AI-driven drug development programs.
Key responsibilities include developing and executing CMC regulatory strategies for drug substance, drug product, analytical methods, manufacturing processes, controls, specifications, stability, and packaging. The successful candidate will lead planning, authoring, review, and coordination of CMC content for INDs, CTAs, amendments, annual reports, and other global regulatory filings. The role requires close partnership with Technical Operations, Process Chemistry, Analytical Development, Formulation, Manufacturing, Quality, Clinical, Nonclinical, and Regulatory Operations teams, as well as external development and manufacturing partners.
The position involves providing regulatory guidance on phase-appropriate control strategies, comparability, specifications, stability, manufacturing changes, technology transfer, and process validation. The candidate will represent Iambic in CMC-focused interactions with the US FDA and global health authorities, including meeting preparation and responses to regulatory inquiries. Additional responsibilities include monitoring global CMC regulations, identifying regulatory risks and gaps, developing mitigation strategies, and supporting due diligence and vendor oversight.
Required qualifications include a Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering, or related discipline (advanced degree preferred). The role typically requires 8+ years of relevant pharmaceutical or biotechnology experience for Associate Director level, or 10+ years for Director level, with substantial CMC regulatory affairs experience. Candidates should have demonstrated experience developing CMC regulatory strategy and preparing Module 3/Quality content for clinical-stage submissions, with small-molecule experience preferred. Strong knowledge of FDA and ICH CMC requirements, excellent scientific writing and communication skills, and proficiency with regulatory document management tools are essential.
The position is hybrid and based at Iambic's San Diego headquarters, located in a state-of-the-art facility with onsite gym and dining amenities.
