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.