Associate Director or Director Regulatory Affairs CMC
Clinical-stage life-science and technology company that develops medicines using an AI-driven discovery and development platform.
Funding history
About Iambic Therapeutics
Iambic Therapeutics combines proprietary AI technologies, including Enchant and NeuralPLexer, with automated chemistry and biology experimentation to discover and develop small-molecule medicines. Its current pipeline includes clinical and preclinical oncology candidates.
Skills
Candidate Availability
Required and preferred rules are kept separate and reflect the wording in the original posting.
About the Role
You will lead global CMC regulatory strategy and execution across development programs. You will prepare and coordinate CMC submission content, provide regulatory guidance, manage risks, support health-authority interactions, and collaborate with technical, clinical, quality, and external partners.
Requirements
- Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering, or a related discipline
- Typically 8+ years of relevant experience for Associate Director or 10+ years for Director
- Substantial CMC regulatory affairs experience
- Experience developing CMC regulatory strategy and Module 3 or Quality content for clinical-stage submissions
- Knowledge of global CMC requirements, FDA expectations, and ICH expectations
- Scientific writing, communication, collaboration, project management, and problem-solving skills
- Proficiency with regulatory information management, publishing, analysis, and Microsoft Office tools
Responsibilities
- Develop and execute global CMC regulatory strategies
- Lead planning, authoring, review, coordination, and delivery of CMC content for regulatory filings
- Partner with technical, manufacturing, quality, clinical, and external development organizations
- Provide guidance on control strategies, comparability, specifications, stability, manufacturing changes, and validation
- Represent the company in CMC-focused interactions with health authorities
- Monitor global CMC regulations and mitigate regulatory risks
- Support due diligence, vendor oversight, and CMC regulatory capability planning
- Develop and maintain standard operating procedures
Benefits
- Company-paid healthcare
- Flexible spending accounts
- Voluntary life insurance
- 401K matching
- Uncapped vacation
- Onsite gym
- Onsite dining