As a Director, Senior Director, or Executive Director of Regulatory Affairs at BBOT, you are driving the development of innovative precision medicines for patients with cancers driven by validated molecular targets. This role entails leading regulatory strategies, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to advance BBOT's pipeline of differentiated therapies. By joining BBOT, you are contributing to the company's mission to leverage cutting-edge structure-based drug discovery to improve patient outcomes. The impact and scope of this position are significant, with the potential to influence the regulatory landscape and shape the future of oncology treatments. With BBOT's commitment to scientific excellence, operational agility, and patient-centricity, you will have opportunities for growth and advancement, expanding your expertise and leadership skills in a dynamic and innovative environment.
Your key responsibilities include developing and implementing regulatory strategies, managing regulatory submissions, and ensuring compliance with Good Clinical Practice (GCP) and other regulatory requirements. Specifically, your day-to-day activities will involve:
- Leading the development of regulatory plans and strategies for BBOT's pipeline products
- Collaborating with cross-functional teams, including research and development, clinical operations, and quality assurance
- Managing and preparing regulatory submissions, including Investigational New Drug (IND) applications and New Drug Applications (NDAs)
- Ensuring compliance with regulatory requirements, including GCP, due diligence, and cancer biology
- Providing regulatory guidance and expertise to support business development and licensing activities
- Developing and maintaining relationships with regulatory agencies, including the FDA
- Staying up-to-date with industry trends and regulatory developments, applying this knowledge to inform regulatory strategies and ensure compliance. As a member of the BBOT team, you will be working remotely from anywhere in the USA, collaborating with a talented and dedicated team of professionals who share your passion for improving patient outcomes.
By joining BBOT, you are becoming part of a company that values scientific excellence, operational agility, and an unwavering commitment to patients. As a Director, Senior Director