Regulatory Affairs Associate Director

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.

• 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.

• 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.

• 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