Global CMC Regulatory Affairs Director

Iambic Therapeutics, Inc; San Diego (CA); Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Company-paid healthcare

401K matching

Uncapped vacation

Onsite gym and dining facilities

Job summary

Iambic Therapeutics, based in San Diego, seeks an Associate Director/Director of Regulatory Affairs - CMC to lead global CMC strategy and execution. You will prepare high-quality CMC content for regulatory submissions, guide phase-appropriate strategies, and partner across functions and with regulators to ensure timely development milestones.

The role requires strong scientific writing, cross-functional leadership, and in-depth knowledge of FDA and ICH expectations, with hybrid work in our San

Qualifications

• Experience developing CMC regulatory strategy for clinical programs.
• Preparing or reviewing Module 3/Quality content for clinical-stage submissions.
• Ability to manage multiple programs and timelines in a fast-paced environment.
• Excellent scientific writing and cross-functional collaboration abilities.

Responsibilities

• Develop and execute global CMC regulatory strategies for drug substance, drug product, analytical methods, and lifecycle activities.
• Lead planning, authoring, review, and timely delivery of CMC content for INDs, CTAs, amendments, and annual reports.
• Collaborate with internal functions and external partners to ensure integrated CMC plans.
• Provide regulatory guidance on control strategies, specs, stability, and process changes.
• Represent Iambic in CMC interactions with FDA and global health authorities.
• Monitor global CMC regulations and communicate risks and potential impacts on submissions.
• Support due diligence, vendor oversight, and planning for CMC capabilities and headcount.
• Develop and maintain SOPs aligned with company values and regulations.

Skills

CMC regulatory strategy

Module 3/Quality content

Cross-functional collaboration

Regulatory writing

Regulatory operations knowledge

Education

Bachelor’s degree in chemistry or related field

Advanced degree preferred

Tools

Regulatory information management systems

Job description

Iambic Therapeutics, based in San Diego, seeks an Associate Director/Director of Regulatory Affairs - CMC to lead global CMC strategy and execution. You will prepare high-quality CMC content for regulatory submissions, guide phase-appropriate strategies, and partner across functions and with regulators to ensure timely development milestones.

The role requires strong scientific writing, cross-functional leadership, and in-depth knowledge of FDA and ICH expectations, with hybrid work in our San