ASSOCIATE DIRECTOR, PROJECT MANAGER – REGULATORY AFFAIRS

Location: San Diego, California – on-site (face-to-face work with colleagues is an essential job function; no role is 100% remote). Travel less than 10% domestic and international.

About the role

The Associate Director, Regulatory Project Manager (RPM) leads and coordinates global regulatory affairs activities to ensure compliance with health authority requirements. This role supports regulatory submissions for investigational and commercial rare disease therapies, facilitates cross-functional collaboration, and manages timelines to achieve company objectives in a fast-paced, patient-focused environment.

Responsibilities

• Lead regulatory project management activities for one or more global development programs, ensuring regulatory plans, timelines, deliverables, and submission activities align with program strategy and corporate priorities.
• Partner closely with Regulatory Leads to drive Global Regulatory Team meeting operations, including agenda planning, decision tracking, meeting documentation, and follow-up on key actions and commitments.
• Develop, maintain, and manage integrated regulatory project timelines that reflect global health authority milestones, cross-functional dependencies, submission deliverables, and key decision points across the product lifecycle.
• Oversee planning and tracking of major regulatory submissions and maintenance activities, including INDs, NDAs, BLAs, supplements, annual reports, DSURs, post-marketing commitments, health authority responses, and other regulatory deliverables.
• Collaborate with Regulatory Operations, Regulatory Affairs, Clinical Development, Clinical Operations, CMC, Biostatistics, Medical Writing, Quality, Commercial, and external partners/vendors to ensure timely and high-quality execution of regulatory deliverables.
• Support submission planning and operational readiness by coordinating content planning, submission timelines, document ownership, review cycles, and Vault RIM-related activities in partnership with Regulatory Operations and Regulatory Leads.
• Create and maintain regulatory dashboards, milestone trackers, and status reports to provide visibility to Regulatory Affairs leadership, program teams, and senior management on progress, risks, issues, and upcoming deliverables.
• Identify, communicate, and help mitigate regulatory project risks, timeline constraints, resource gaps, and cross-functional dependencies that may impact submission readiness, health authority commitments, or program execution.
• Support preparation for health authority interactions, advisory committee activities, inspection readiness, audits, and regulatory responses by coordinating timelines, materials, contributors, and action follow-up.
• Drive continuous improvement of regulatory project management processes, tools, templates, meeting operations, dashboards, and ways of working to improve consistency, efficiency, and scalability across programs.
• Manage regulatory project documentation and ensure key decisions, action items, timelines, submission plans, and deliverables are appropriately captured, maintained, and accessible in designated systems or repositories.
• Provide leadership, mentoring, and guidance to regulatory project management team members and cross-functional partners; may manage direct reports or support resource planning across multiple programs as the function evolves.
• Perform additional duties as assigned.

Requirements

• Bachelor’s degree in Life Sciences or a related discipline required; MS, Pharm D, or PhD preferred. Equivalent combination of education and applicable job experience may be considered.
• 8+ years of project management experience in the biotech or pharmaceutical industry; regulatory-specific project management experience preferred.
• PMP certification strongly preferred.
• Expertise with timeline development and management software (e.g., Smartsheets, MS Project).
• Strong understanding of global regulatory affairs, submission requirements, and compliance processes for rare disease therapies.
• Proven ability to create and manage complex project plans, timelines, budgets, and critical paths.
• Excellent project management skills, including scheduling, risk management, and stakeholder coordination in a fast-paced biotech setting.
• Strong communication, organizational, and problem-solving skills to drive regulatory initiatives aligned with a patient-first mission.
• Ability to adapt to modifications and changes to project plans, demonstrating flexibility to implement new strategies and tactics.

Skills

• Embodies company core values: Courage, Community Spirit, Patient Focus, and Teamwork.
• Driven, intelligent, and passionate about making a difference for patients with rare diseases.
• Well-organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.

Pay

Compensation based on level and experience, with a range of $150,000–$195,000.