Associate Director, Regulatory Affairs

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.
• Experience developing and negotiating clinical-regulatory strategies with health authorities, including ex-U.S. agencies.
• Experience with the creation, submission, and negotiation of regulatory applications is preferred.
• Ability to develop, write, edit, and/or collaborate on high-quality clinical-regulatory documents.
• Experience with materials such as briefing books, investigator brochures, protocols, clinical study reports, and clinical summaries.
• Strong ability to communicate clearly and concisely within established timelines.
• Ability to manage multiple regulatory projects and submissions simultaneously.
• Flexibility to adjust priorities in response to new clinical data, program changes, and external regulatory developments.
• Exceptional attention to detail and commitment to accuracy.
• Strong organizational, planning, and project management skills.
• Ability to influence and negotiate professionally with cross-functional teams and external partners.
• Excellent interpersonal, verbal, and written communication skills.
• Strong judgment, analytical thinking, troubleshooting, and problem-solving abilities.
• Advanced degree such as MS, MPH, PharmD, or PhD preferred.
• Experience with biologics, cell and gene therapies, or advanced therapy medicinal products is preferred.
• Ability to work effectively in a remote professional environment.

Benefits:

• Salary: $185,000–$210,000 USD annual base salary.
• Work Model: Fully remote position.
• Career Scope: Leadership responsibility across U.S. and global regulatory strategies and submissions.
• Global Exposure: Opportunities to engage with regulatory authorities across North America, Europe, Australia, and other international markets.
• Scientific Environment: Work involving innovative biologic development and novel cell and gene therapy approaches in oncology.
• Cross-Functional Collaboration: Partner with clinical development and other functional leaders on complex development programs.
• Professional Growth: Exposure to regulatory strategy, health authority interactions, clinical development, and global submissions.
• Work Environment: Professional remote-office setting with standard office equipment and computer-based work.
• Accessibility: Reasonable accommodations are available to support qualified individuals in performing the essential functions of the role.