Associate Director, Regulatory Affairs

Accountabilities

• • 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.

  Requirements

  • 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%.

  Benefits

  • 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-focused, and committed to solving challenging scientific problems.