Associate Director, Regulatory Affairs

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Regulatory Affairs based in United States. This is a strategic regulatory leadership role supporting innovative biologic development programs in oncology. You will lead regulatory strategy across U.S. and international markets, helping shape development pathways and submission plans. The role offers broad exposure to clinical development, global health authorities, and novel cell and gene therapy programs. You will work closely with cross-functional leaders to align regulatory strategy, manage risks, and advance programs efficiently. You will also lead preparation for health authority interactions and contribute to high-quality clinical and regulatory submissions. Success in this role requires strong scientific judgment, clear communication, attention to detail, and the ability to influence complex decisions. This fully remote opportunity offers a base salary of $185,000–$210,000 and the opportunity to contribute to innovative oncology therapies.