Director of Regulatory Affairs

Director of Regulatory Affairs About the Company A leading biotechnology company committed to developing innovative treatments. Industry Biotechnology Type Privately Held About the Role We are searching for a dynamic Director of Regulatory Affairs to lead our regulatory initiatives and ensure the successful registration and compliance of our products. This pivotal role involves shaping and executing regulatory strategies that meet both regional and global standards, particularly those mandated by regulatory agencies. The ideal candidate will drive regulatory strategic direction for our non-clinical and clinical development programs, oversee the preparation and submission of essential regulatory documents, including INDs, NDAs, BLAs, and MAAs, and act as the primary liaison with regulatory authorities. Key responsibilities include: Leading and managing the preparation, review, and submission of various regulatory documents. Staying informed on updates in regulations, guidelines, and legislation, and interpreting their impact on the organization. Providing expert guidance on compliance issues and identifying potential risks. Collaborating effectively with cross-functional teams to integrate regulatory requirements into development plans, clinical studies, and manufacturing processes. Conducting risk assessments and implementing mitigation strategies. Developing and maintaining standard operating procedures and regulatory policies to ensure continuous compliance. Travel Percent Less than 10% Functions Operations

Created: 2026-03-10