Director, Global Regulatory Affairs Project Management

The Opportunity:

The Director, Global Regulatory Affairs Project Management is an integral part of the global Regulatory Affairs organization and is responsible for translating global regulatory strategies into actionable execution plans.  This role applies advanced project management expertise and operational leadership to guide cross-functional teams, supporting planned and ongoing drug marketing applications across RevMed programs.  The role partners closely with Global Regulatory Science and Global Filing and Registration and contributes to the broader Global Regulatory Affairs function at RevMed.  This position reports to the Senior Director, Global Regulatory Affairs Project Management.

The ideal candidate will have an in-depth understanding of oncology drug development and demonstrated hands-on regulatory project management experience supporting early- and late-stage registrational programs, including the execution of global new drug marketing applications, in alignment with corporate objectives. 

Core Responsibilities:

• Project manage regulatory submissions from initiation through submission, supporting the definition of scope, timelines, prioritization, resource needs, and key deliverables.

• Develop, maintain, and track comprehensive submission timelines for INDs / CTAs, NDAs / MAAs, amendments, agency interactions, and other key global regulatory activities.

• Partner with Global and Regional Regulatory Science Leads to advance global regulatory strategies for assigned molecules across indications.

• Facilitate Global Regulatory Teams and meetings to ensure coordinated development and execution of high-quality, timely global regulatory deliverables at the study level.

• Partner with Global Filing Leads on planning, resourcing, and execution of new drug marketing applications for global agency submissions, interactions, and approvals.

• Drive the operational planning, coordination, and tracking of new drug marketing application submission activities across cross-functional Filing Teams (including Regulatory, Medical Writing, Nonclinical, Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and Manufacturing, etc. and external consultants), supporting the Global Filing Lead’s strategic vision.

• Coordinate with global partners to maintain consistent regulatory program plans, ensuring alignment, compliance, and continuity across regions.

• Proactively identify operational risks, gaps, and bottlenecks; propose and implement solutions, including process improvements and outsourcing strategies, as appropriate.

• Build and maintain submission dashboards; communicate status, risks, and mitigation strategies to senior management and key stakeholders.

• Support the development, implementation, and continuous improvement of global regulatory project management processes, templates, tools, dashboards, analytics, and best practices.

• Champion innovation and operational excellence, identifying opportunities to streamline regulatory project management and enhance submission preparation efficiency and scalability.

Required Skills, Experience and Education:

• Bachelor’s degree in a life sciences or related discipline; advanced degree preferred.

• 15+ years of pharma / biotech industry experience, including 8-10 years of regulatory project management experience. Hands-on U.S. drug marketing application experience required.

• Strong working knowledge of global regulatory regulations, guidelines, and submission pathways; familiarity with nonclinical, clinical, and CMC (bio)pharmaceutical development.

• In-depth knowledge of CTD structure and dossier component management, including coordination across cross-functional filing team contributors and senior leadership.

• Exceptional project management skills with proven ability to manage multiple complex programs under compressed timelines in a fast-paced, cross-functional environment that values both speed and quality.

• Excellent communication and interpersonal skills, with demonstrated ability to influence, manage group dynamics, and balance functional, team, and leadership objectives.

• Ability to think both strategically and tactically and present recommendations to senior leadership and key stakeholders.

• High proficiency with project management tools including Smartsheet and Microsoft Project, and familiarity with WBS management, timeline development, and critical path analysis; experience with OnePager, Office Timeline, and Veeva RIM is a plus.

Preferred Skills:

• Experience supporting global regulatory filings including Japan, Canada, and EU / UK submissions.

• Oncology drug development experience.

• Experience with complex oncology clinical trial designs (e.g., combination studies, multi-cohort expansions, basket or umbrella master protocols). 

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