Director of Regulatory Affairs

Director of Regulatory Affairs About the Company A leading biotechnology company dedicated to developing groundbreaking treatments. Industry Biotechnology Type Privately Held About the Role The company is actively searching for a Director of Regulatory Affairs to deliver strategic leadership and oversee all regulatory activities essential for the successful development and registration of its innovative products. This pivotal position involves crafting and executing robust regulatory strategies to ensure adherence to both regional and global standards, particularly those mandated by regulatory authorities. The ideal candidate will provide vital regulatory input for both non-clinical and clinical development initiatives, lead the comprehensive preparation of various regulatory submissions, and act as the primary liaison with regulatory agencies. Key responsibilities include: Organizing, overseeing, and managing the preparation, review, and submission of diverse regulatory documents, including INDs, NDAs, BLAs, and MAAs. Staying informed on and interpreting modifications in regulations, guidelines, and legislation. Offering guidance on compliance issues and identifying potential risks. Collaborating with cross-functional teams to embed regulatory requirements into development plans, clinical trials, and manufacturing operations. Conducting risk assessments, developing mitigation strategies, and maintaining standard operating procedures and regulatory policies to ensure continuous compliance. Travel Percent Less than 10% Functions Operations