Associate Director, Project Manager - Regulatory Affairs

Accountabilities:

• • Lead regulatory project management activities across one or more global development programs, ensuring regulatory plans, timelines, deliverables, and submission activities align with program strategy and organizational priorities.
  • Partner with Regulatory Leads to coordinate global regulatory team meetings, including agendas, decisions, documentation, action tracking, and follow-up on commitments.
  • Develop and maintain integrated regulatory project plans and timelines covering health authority milestones, cross-functional dependencies, submission deliverables, and key program decisions.
  • Plan and track major regulatory submissions and maintenance activities, including INDs, NDAs, BLAs, supplements, annual reports, DSURs, post-marketing commitments, health authority responses, and other regulatory deliverables.
  • Coordinate with Regulatory Operations, Clinical Development, Clinical Operations, CMC, Biostatistics, Medical Writing, Quality, Commercial teams, and external vendors to ensure timely and high-quality execution.
  • Support submission readiness by coordinating content plans, document ownership, review cycles, submission timelines, and regulatory information management activities.
  • Create dashboards, milestone trackers, and status reports that provide leadership and program teams with clear visibility into progress, risks, dependencies, and upcoming deliverables.
  • Identify and communicate regulatory project risks, resource constraints, timeline challenges, and cross-functional dependencies, helping teams develop mitigation strategies.
  • Coordinate preparation for health authority interactions, advisory committees, inspections, audits, and regulatory responses, including timelines, materials, contributors, and follow-up actions.
  • Drive continuous improvement of regulatory project management processes, tools, templates, meeting practices, dashboards, and operating models to increase consistency and scalability.
  • Maintain accurate regulatory project documentation, including decisions, action items, submission plans, timelines, and key deliverables within designated systems and repositories.
  • Provide leadership, mentoring, and guidance to regulatory project management colleagues and cross-functional partners, with potential responsibility for direct reports or resource planning as the function develops.

  Requirements:

  • Bachelor’s degree in Life Sciences or a related discipline is required; a Master’s degree, PharmD, or PhD is preferred. Equivalent combinations of education and relevant professional experience may be considered.
  • 8+ years of project management experience within the biotechnology or pharmaceutical industry, with regulatory project management experience strongly preferred.
  • Strong understanding of global regulatory affairs, submission requirements, compliance processes, and the development of therapies for rare diseases.
  • Proven experience creating and managing complex project plans, integrated timelines, critical paths, budgets, milestones, and cross-functional dependencies.
  • Demonstrated expertise with timeline and project management tools such as Smartsheet or Microsoft Project.
  • PMP certification is strongly preferred.
  • Strong stakeholder management skills and the ability to collaborate effectively with Regulatory Affairs, Clinical, CMC, Quality, Operations, Medical Writing, Commercial, and external partners.
  • Excellent organizational, analytical, communication, facilitation, and problem-solving abilities, with a proven capacity to manage multiple priorities in a dynamic environment.
  • Ability to identify risks, adapt project plans, respond to changing priorities, and implement practical strategies to maintain program momentum.
  • Strong executive communication skills, including the ability to translate complex project information into concise status updates, dashboards, and actionable recommendations.
  • Demonstrated ability to influence and coordinate stakeholders across functions, with or without direct authority.
  • A collaborative, patient-focused mindset combined with sound judgment, accountability, flexibility, and attention to detail.
  • Willingness and ability to travel less than 10% domestically and internationally.
  • Ability to participate in face-to-face collaboration and occasional onsite work in San Diego; the role is not expected to be 100% remote.

  Benefits:

  • Target base salary range of $150,000–$195,000 USD, with actual compensation determined by experience, education, skills, and location.
  • Short-term incentive compensation and long-term incentive opportunities through company equity.
  • Comprehensive health, financial, work-life, and well-being benefits for eligible employees and dependents.
  • Medical and wellness programs, employee support resources, life insurance, and disability coverage.
  • Retirement plans with employer contributions/match.
  • Generous paid time off.
  • Collaborative, people-focused environment centered on professional growth and meaningful patient impact.
  • Opportunity to contribute to global regulatory programs supporting therapies for rare diseases.
  • Flexible work arrangement with remote eligibility while maintaining opportunities for in-person collaboration in San Diego.
  • Ongoing opportunities to develop leadership, regulatory project management, and cross-functional capabilities.