Associate Director, Regulatory Affairs – CMC Small Molecules

Overview You will lead global CMC regulatory strategy and author high-quality submission content for small-molecule programs. In this role, you partner with process chemistry, analytical development, drug product, and QA to shape CMC strategy and ensure compliance across submissions. You will serve as the primary CMC regulatory contact, navigate health authority interactions, and help scale regulatory processes as the company advances. You will work in a fast-paced, cross-functional environment to deliver robust, timely IND/CTA through NDA/MAA milestones. This is an opportunity to impact late-stage development and commercialization within a mission-driven biotech. Verantwortungsbereiche Develop and execute global CMC regulatory strategies for small-molecule programs across development phases Author, review, and finalize Module 3 content, Module 2.3 Quality Overall Summary, IMPD, and responses to information requests Act as the primary CMC regulatory point of contact for assigned programs; coordinate input across cross-functional teams Lead CMC regulatory risk assessments and propose mitigation plans with technical teams Support health authority interactions (FDA, EMA, and others) including pre-IND meetings and response letters Monitor evolving global CMC guidance and advise internal stakeholders on implications Contribute to development and maintenance of internal CMC regulatory SOPs, templates, and best practices Zentrale Anforderungen Minimum 8 years of progressive CMC Regulatory Affairs experience in biotech/pharma Direct authorship of Module 3 content for small-molecule programs Experience supporting IND/CTA submissions; involvement in NDA/MAA/BLA CMC submissions is highly desirable Strong knowledge of ICH guidelines, FDA/EMA CMC requirements, and cGMP Experience with CDMOs/CMOs and cross-functional development teams in outsourced manufacturing Excellent scientific writing and communication skills; ability to translate data into regulatory narrative Strong project management; ability to manage multiple submissions and timelines Experience with eCTD structure and lifecycle management and electronic submission publishing tools clear communication cross-functional collaboration proactive problem-solving CMC regulatory strategy Module 3 authoring IND/CTA submissions