Associate Director / Director, Regulatory Affairs - CMC

Iambic Therapeutics, Inc•San Diego, CA

8h•$164,000 - $245,000•Hybrid

About The Position

The Associate Director/Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) will lead global CMC regulatory strategy and execution across Iambic's development programs. The role will prepare and oversee high-quality CMC content for regulatory submissions, provide phase-appropriate regulatory guidance, identify and mitigate risks, and ensure alignment with program objectives and global requirements. This individual will partner closely with Technical Operations, Process Chemistry, Analytical Development, Formulation, Manufacturing, Quality, Clinical, Nonclinical, Regulatory Operations, and external partners, and will support interactions with the US FDA and other global health authorities as appropriate. Level will be determined by education, depth of CMC regulatory experience, leadership, and scope of prior responsibilities. This position will be hybrid and based in our San Diego Headquarters.

Requirements

Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering, or a related discipline; advanced degree preferred.
Typically 8+ years of relevant pharmaceutical or biotechnology experience for Associate Director and 10+ years for Director, including substantial CMC regulatory affairs experience.
Equivalent combinations of education and experience may be considered.
Demonstrated experience developing CMC regulatory strategy and preparing or reviewing Module 3/Quality content for clinical-stage submissions; small-molecule experience is preferred.
Ability to manage multiple programs and workstreams, establish priorities, maintain submission timelines, and deliver high-quality work in a fast-paced, dynamic, cross-functional environment.
Strong knowledge of global CMC requirements and guidance, including FDA and ICH expectations
Excellent scientific writing, communication, collaboration, project management, and problem-solving skills; strong attention to detail
Proficiency with regulatory document/submission tools, including regulatory information management, publishing and analysis tools and Microsoft Office.

Nice To Haves

advanced degree preferred
small-molecule experience is preferred

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 the planning, authoring, review, coordination, and timely delivery of CMC content for INDs, CTAs, amendments, annual reports, briefing packages, health authority responses, and other global filings.
Partner with Technical Operations, Process Chemistry, Analytical Development, Formulation, Manufacturing, Quality, Clinical, Nonclinical, Regulatory Operations, and external development and manufacturing organizations to ensure integrated CMC plans.
Provide regulatory guidance on phase-appropriate control strategies, comparability, specifications, stability, manufacturing changes, technology transfer, process validation, and later-stage readiness.
Represent Iambic in certain CMC-focused interactions with the US FDA and global health authorities, including meeting preparation, briefing materials, responses, and commitments.
Monitor global CMC regulations, identify CMC regulatory risks, gaps, and dependencies; develop mitigation strategies and communicate collected intelligence, precedence and potential impacts on program timelines, submission plans, and product development decisions.
Support due diligence, external partnerships, vendor oversight, and fit-for-purpose planning for CMC regulatory capabilities, systems, consultants, and headcount.
Develop and maintain relevant standard operating procedures and perform all duties in alignment with Iambic's core values, policies, quality systems, and applicable regulations.