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 the United States.

This is an opportunity to play a key role in advancing innovative therapies for patients with serious diseases within a clinical-stage biotechnology environment.

• Contribute to the development and execution of global regulatory strategies, providing actionable regulatory guidance to cross-functional teams and ensuring strategies evolve with changing regulatory and business requirements.
• Support end-to-end regulatory planning and execution for submissions, including INDs, NDAs, BLAs, briefing packages, and orphan drug applications.
• Serve as a regulatory liaison with the FDA and other global health authorities as assigned, supporting effective and well-prepared agency interactions.
• Prepare briefing materials and coordinate internal preparation for FDA and other health authority meetings, ensuring teams are aligned on objectives, messaging, and supporting documentation.
• Communicate regulatory risks, milestones, timelines, requirements, and strategic updates clearly to senior leadership, project teams, and external stakeholders.
• Represent Regulatory Affairs on Project, Clinical, and Study Teams, ensuring regulatory considerations remain aligned with broader development objectives.
• Help coordinate cross-functional regulatory submission teams and ensure high-quality, timely contributions from internal stakeholders, consultants, and external partners.
• Support the selection, management, and oversight of regulatory consultants, CROs, and other external vendors.
• Monitor regulatory intelligence, including changes to legislation, guidelines, regulatory expectations, and global health authority practices, and translate relevant developments into actionable recommendations.
• Develop, maintain, and improve regulatory SOPs, processes, and best practices to promote operational excellence and compliance.
• Ensure regulatory strategies and activities remain compliant with applicable regulations, guidance, and internal standards.
• Participate in regulatory due diligence and provide regulatory insights during business development and strategic evaluation activities.
• Apply AI tools effectively in day-to-day regulatory work to improve research, analysis, productivity, and operational efficiency.

• Bachelor’s degree in a scientific discipline or equivalent professional experience required; an advanced degree such as an MS, PhD, or PharmD is preferred.
• 7+ years of experience in the pharmaceutical or biotechnology industry, including at least 4 years in Regulatory Affairs.
• Demonstrated experience in oncology and across multiple stages of drug development.
• Proven experience preparing and supporting global regulatory submissions, particularly FDA NDA and BLA filings.
• Global regulatory experience and familiarity with international regulatory pathways are strongly preferred.
• Strong working knowledge of the drug development process, regulatory frameworks, guidelines, and their practical application.
• Experience supporting interactions with the FDA and other health authorities, including preparation for agency meetings.
• Strong interpersonal, communication, collaboration, and leadership skills, with the ability to influence cross-functional teams and external partners.
• Excellent organizational and project management abilities, with the capacity to manage multiple priorities, deadlines, and complex workstreams.
• Proactive, analytical, and detail-oriented approach with strong strategic thinking and problem-solving capabilities.
• Ability to communicate complex regulatory concepts clearly to technical and non-technical stakeholders.
• Demonstrated proficiency with AI tools for routine professional work; advanced or innovative application of AI is a strong advantage.
• Comfortable operating in a dynamic, collaborative, and mission-driven biotech environment with evolving priorities.
• Ability to travel up to 10%.

• Base salary: $170,000–$195,000, depending on experience, qualifications, and internal practices.
• Annual target bonus as part of the overall compensation package.
• Equity participation, providing an opportunity to share in the organization’s long-term success.
• Comprehensive benefits package designed to support employees’ health, well-being, and overall needs.
• Opportunity to contribute to the development of innovative therapies addressing serious diseases and significant unmet medical needs.
• Collaborative, science-driven environment focused on innovation, patient impact, and continuous learning.
• Exposure to complex global regulatory programs spanning oncology, rare disease, and multiple stages of development.
• Opportunity to work cross-functionally with experienced teams across clinical development, regulatory, and other disciplines.
• Culture built around being growth-minded, collaborative, patient