Project Manager, Regulatory Affairs / Quality Assurance

Intuitive•Sunnyvale, CA

About The Position

The Regulatory Affairs and Quality Assurance (RAQA) Project Manager serves as a strategic project management partner to Regulatory Affairs & Quality Assurance leadership, with integrated project management responsibility for regulatory strategy execution and quality-assurance readiness across development programs. The role translates regulatory strategies, health authority requirements, quality-system obligations, and technical decisions into coordinated cross-functional plans from clinical development through marketing application submission, approval, launch readiness, and post-approval lifecycle management. Reporting to the Program Management & Operations organization, the RAQA Project Manager partners closely with Regulatory Affairs, Quality Assurance, Chemistry, Manufacturing, and Controls (CMC), Clinical Development, Clinical Development & Operations, Biostatistics, Medical Writing, Pharmacovigilance, Supply Chain, Commercial, Legal, and external partners. The position places primary emphasis on regulatory planning, submission execution, health authority engagement, regulatory commitments, and inspection and compliance readiness, while integrating associated Quality Assurance activities into unified project plans.

Requirements

Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Regulatory Affairs, Quality, Chemistry, Engineering, Business, or a related field, or equivalent experience.
Minimum of 8 years of pharmaceutical or biotechnology industry experience, including substantial experience supporting Regulatory Affairs activities and at least 3 years of cross-functional program or project management responsibility.
Demonstrated experience supporting small-molecule development programs from clinical development through NDA submission, health authority review, approval, and launch readiness.
Strong working knowledge of U.S. Food and Drug Administration requirements, regulatory submission processes, electronic Common Technical Document (eCTD) structure, health authority interactions, labeling, regulatory commitments, and post-approval lifecycle activities.
Demonstrated ability to develop and manage integrated submission plans, content plans, regulatory timelines, review workflows, dependency maps, RAID logs, decision logs, and executive-readiness reporting.
Working knowledge of pharmaceutical Quality Assurance and GxP quality systems, including inspection readiness, audits, deviations, CAPA, change control, document control, training compliance, and quality-risk management.
Experience coordinating cross-functional teams across Regulatory Affairs, Quality Assurance, CMC, Clinical, Nonclinical, Biostatistics, Medical Writing, Pharmacovigilance, and Commercial functions.
Excellent communication, facilitation, and presentation skills, with the ability to synthesize complex regulatory issues, clarify decisions, and drive alignment without direct authority.
Advanced proficiency with Smartsheet and Microsoft Office, including detailed project planning, dashboards, reporting, and workflow automation.

Nice To Haves

An advanced scientific or regulatory degree is preferred.
Direct experience coordinating NDA content and submission activities across eCTD Modules 1 through 5, with particular experience integrating CMC, clinical, and nonclinical content.
Experience supporting U.S. Food and Drug Administration meetings, information requests, labeling negotiations, inspections, and post-approval commitments.
Regulatory Affairs Certification (RAC), Project Management Professional (PMP) certification, or comparable credential.
Experience with regulatory information management systems, electronic document management systems, submission publishing tools, quality management systems, and validated workflows.
Familiarity with procurement, contracting, and financial-management systems such as Coupa, Ivalua, SAP, Ariba, or equivalent.

Responsibilities

Partner with Regulatory Affairs leadership to translate global and U.S. regulatory strategies into executable plans, including submission pathways, content plans, review timelines, decision points, dependencies, and resource requirements.
Develop, maintain, and communicate integrated regulatory project plans for assigned programs, covering investigational and marketing applications, amendments, annual reports, meeting requests and briefing packages, responses to health authority information requests, labeling activities, regulatory commitments, and post-approval submissions.
Drive cross-functional planning and operational execution for New Drug Application (NDA) submissions, including integrated content plans across Modules 1 through 5, document authoring and review workflows, publishing and submission-readiness milestones, critical-path management, and final filing activities.
Coordinate regulatory deliverables across Regulatory Affairs, CMC, Clinical, Nonclinical, Quality Assurance, Product Launch, and external partners, ensuring owners, due dates, dependencies, and acceptance criteria are clearly defined.
Plan and facilitate health authority interactions by coordinating meeting strategy, supporting briefing-package development, question-and-answer preparation, rehearsals, meeting logistics, minutes, commitments, and post-meeting action tracking.
Maintain regulatory RAID and decision logs, submission trackers, correspondence logs, commitment registers, and governance materials; proactively identify risks to submission quality, completeness, timing, approvability, or regulatory compliance and facilitate mitigation plans.
Coordinate responses to health authority questions and requests for information by establishing response teams, timelines, review and approval pathways, source-document traceability, and readiness checkpoints.
Support regulatory intelligence and impact assessments by tracking relevant guidance, precedents, policy changes, and agency feedback, and translating potential impacts into program actions, decision requests, and schedule updates.
Integrate Quality Assurance activities that support regulatory execution, including inspection readiness, audit and inspection commitments, corrective and preventive action (CAPA) tracking, deviation and change-control dependencies, document-control requirements, and Good Practice (GxP) compliance deliverables.
Partner with Quality Assurance and functional leaders to coordinate inspection-readiness plans, mock inspections, evidence-room and document requests, subject-matter-expert preparation, response tracking, and remediation follow-through.
Facilitate RAQA governance by preparing decision-focused materials, documenting decisions and actions, monitoring follow-through, and escalating unresolved risks, resource constraints, and cross-functional conflicts through appropriate governance forums.
Develop dashboards and executive reporting that communicate submission readiness, milestone performance, critical-path status, health authority interactions, regulatory risks, quality-readiness indicators, commitments, and decisions required.
Support functional budget and resource planning by tracking forecasts, external regulatory support, publishing and submission costs, consultant and vendor activities, purchase orders, invoices, and inputs to the Annual Operations Budget Planning Cycle.
Coordinate external regulatory consultants, publishing vendors, and other service providers by integrating vendor plans and deliverables, monitoring performance and dependencies, and driving operational follow-up across internal teams.
Apply standardized project management tools, templates, dashboards, reporting practices, and workflow automation to improve visibility, consistency, traceability, and execution across Regulatory Affairs and Quality Assurance.