Director Regulatory Affairs CMC

We are partnering with a well-funded clinical-stage biotechnology company advancing a promising oncology pipeline and seeking a Director, Regulatory Affairs CMC to join their growing Regulatory team. This position will lead Regulatory CMC strategy across development-stage biologic programs, supporting activities from early clinical development through future marketing applications. The role offers significant cross-functional exposure and the opportunity to influence global regulatory strategy within a fast-paced biotech environment. Key Responsibilities Develop and execute global Regulatory CMC strategies. Lead CMC regulatory submissions and health authority interactions. Provide strategic support across development, manufacturing and quality functions. Identify regulatory risks and drive mitigation plans. Manage submission timelines and cross-functional deliverables. Requirements Advanced degree in Chemistry, Biochemistry, Pharmaceutical Sciences or related field. Strong Regulatory Affairs CMC experience for Large Molecules Experience supporting biologics programs and regulatory submissions. Working knowledge of FDA regulations, ICH guidelines and global CMC requirements. Why Join? Innovative oncology-focused biotech. High visibility and strategic influence. Strong pipeline and growth trajectory. Competitive compensation, bonus and equity. #J-18808-Ljbffr