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. Accountabilities: As an Associate Director, Regulatory Affairs, you will lead regulatory activities for one or more drug development programs, with responsibility for U. S. and global regulatory strategy, submissions, and health authority interactions. You will partner closely with clinical and cross-functional teams to establish effective development pathways and ensure regulatory plans remain aligned with evolving data and requirements. - Develop and execute U. S. and global regulatory strategies for assigned development programs. - Collaborate with functional leaders to establish optimal clinical and regulatory development pathways.

- Help negotiate development strategies within cross-functional teams and with health authorities. - Execute clinical-regulatory development plans on schedule while identifying and managing program risks. - Plan, manage, and prepare Clinical Trial Applications, Marketing Applications, and regulatory amendments. - Ensure submission documents and regulatory correspondence meet high standards for content, organization, clarity, and accuracy. - Lead cross-functional teams in developing strategic briefing packages. - Coordinate preparation for health authority meetings, discussions, and other regulatory interactions. - Support regulatory interactions with agencies including Health Canada, MHRA, EMA, Swissmedic, and TGA. - Monitor evolving global regulations, guidelines, and health authority expectations relevant to biologics and advanced therapies. - Incorporate changing regulatory requirements into program strategy and decision-making. - Collaborate with internal teams to identify and implement regulatory process improvements. - Contribute to the development of high-quality clinical-regulatory documents and supporting materials. - Manage multiple projects and submissions simultaneously, adapting priorities as new data, program changes, or external developments arise. - Perform additional regulatory and cross-functional responsibilities as needed. Requirements: The ideal candidate brings substantial regulatory affairs experience within late-stage oncology drug development, along with the scientific expertise and communication skills needed to navigate complex global regulatory environments. Experience with biologics and novel cell or gene therapies is particularly valuable, as is the ability to influence cross-functional decisions while maintaining strong working relationships. - Bachelor’s degree in life sciences required. - Minimum of 5 years of regulatory affairs experience with a doctorate such as MD, PhD, PharmD, or equivalent. - Alternatively, 8 years of regulatory affairs experience with a master’s degree or 10 years with a bachelor’s degree. - Demonstrated experience supporting late-stage oncology drug development programs.