Associate Director / Director, Regulatory Affairs - CMC

Другое

• JOB SUMMARY
• 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
• This position will be hybrid and based in our San Diego Headquarters.
• KEY 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.
• QUALIFICATIONS
• 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.
• ABOUT Company
• Iambic is a clinical-stage life-science and technology company developing novel medicines using its AI-driven discovery and development platform. Based in San Diego and founded in 2020, Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters. The Iambic platform has demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed and across multiple target classes and mechanisms of action. Iambic is advancing a pipeline of potential best-in-class and first-in-class clinical assets, both internally and in partnership, to address urgent unmet patient need. Learn more about the Iambic team, platform, pipeline, and partnerships at.
• MISSION & CORE VALUES
• Our mission is to deliver better medicines through innovations in AI-based discovery technologies. The culture and work at Company are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies.
• PAY AND BENEFITS
• We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.