Associate Director, Regulatory Affairs - CMC (Hybrid)

Regulatory Jobs; San Diego (CA); Hybrid; USD 170,000 - 230,000; Full time

Benefits offered by this job

Healthcare

401K matching

Uncapped vacation

Onsite gym

Dining

Flexible spending accounts

Job summary

Iambic Therapeutics seeks an Associate Director/Director of Regulatory Affairs - CMC to lead global CMC strategy and content for regulatory submissions across development programs. You will guide phase-appropriate regulatory decisions and collaborate with Operations, Analytical Development, Quality, Clinical, and external partners, ensuring alignment with global requirements.

The role interfaces with US FDA and health authorities, with a hybrid work model based in San Diego.

Qualifications

• Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering, or related discipline.
• Typically 8+ years of pharmaceutical/biotechnology experience for Associate Director and 10+ for Director, including substantial CMC regulatory affairs experience.
• Demonstrated experience developing CMC regulatory strategy and preparing Module 3/Quality content for clinical-stage submissions.

Responsibilities

• Develop and execute global CMC regulatory strategies for drug substance, drug product, analytical methods, manufacturing processes, controls, specifications, stability, packaging, and lifecycle activities.
• Lead planning, authoring, review, coordination, and timely delivery of CMC content for INDs, CTAs, amendments, annual reports, briefing packages, health authority responses, and global filings.
• Partner with cross-functional teams to ensure integrated CMC plans.
• Provide regulatory guidance on control strategies, comparability, specifications, stability, manufacturing changes, technology transfer, and process validation.
• Represent the company in CMC-focused interactions with FDA and global health authorities, including meeting prep and responses.
• Monitor global CMC regulations, identify risks and dependencies; develop mitigation strategies and communicate potential impacts on timelines and submissions.
• Support due diligence, partnerships, vendor oversight, and headcount planning for CMC regulatory capabilities.
• Develop and maintain SOPs, aligning with company values, quality systems, and regulations.

Education

Bachelor's degree in chemistry or related

Advanced degree preferred

Job description

Iambic Therapeutics seeks an Associate Director/Director of Regulatory Affairs - CMC to lead global CMC strategy and content for regulatory submissions across development programs. You will guide phase-appropriate regulatory decisions and collaborate with Operations, Analytical Development, Quality, Clinical, and external partners, ensuring alignment with global requirements.

The role interfaces with US FDA and health authorities, with a hybrid work model based in San Diego.