Associate Director, Project Manager - Regulatory Affairs

Lead and coordinate global regulatory affairs activities to ensure compliance with health authority requirements for investigational and commercial rare disease therapies. Partner with cross-functional teams to manage timelines, submissions, and regulatory commitments in a fast-paced, patient-focused environment.

Responsibilities

• Lead regulatory project management activities for one or more global development programs, ensuring alignment with program strategy and corporate priorities.
• Partner with Regulatory Leads to drive Global Regulatory Team meeting operations, including agenda planning, decision tracking, meeting documentation, and follow-up on key actions.
• Develop, maintain, and manage integrated regulatory project timelines reflecting global health authority milestones, cross-functional dependencies, and submission deliverables.
• Oversee planning and tracking of major regulatory submissions (INDs, NDAs, BLAs, supplements, annual reports, DSURs) and post-marketing commitments.
• Collaborate with Regulatory Operations, Clinical Development, CMC, Biostatistics, Medical Writing, Quality, Commercial, and external partners to ensure timely execution of deliverables.
• Support submission planning and operational readiness by coordinating content, timelines, document ownership, review cycles, and Vault RIM-related activities.
• Create and maintain regulatory dashboards, milestone trackers, and status reports for leadership and senior management.
• Identify, communicate, and mitigate regulatory project risks, timeline constraints, and resource gaps impacting submission readiness or program execution.
• Support health authority interactions, advisory committee activities, inspection readiness, audits, and regulatory responses by coordinating timelines and materials.
• Drive continuous improvement of regulatory project management processes, tools, templates, and meeting operations.
• Manage regulatory project documentation, ensuring key decisions, action items, and deliverables are captured and accessible.
• Provide leadership, mentoring, and guidance to team members and cross-functional partners; may manage direct reports or support resource planning.

Requirements

• Bachelor’s degree in Life Sciences or related discipline; MS, PharmD, or PhD preferred. Equivalent experience may be considered.
• 8+ years of project management experience in biotech or pharmaceutical industry; regulatory-specific 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.
• Ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional environment.
• Excellent project management skills, including scheduling, risk management, and stakeholder coordination.
• Proven ability to create and manage complex project plans, timelines, budgets, and critical paths.
• Adaptability to modify project plans and implement new strategies as needed.
• Travel required: less than 10% domestic and international.
• Position requires onsite work in San Diego; no role is 100% remote.

Skills

• Embodies core values: Courage, Community Spirit, Patient Focus, and Teamwork.
• Driven, intelligent, and passionate about making a difference for patients with rare diseases.
• Strong communication, organizational, and problem-solving skills.

Pay

Compensation range: $150,000–$195,000, commensurate with experience and level.