Senior Regulatory Affairs Consultant - Regulatory Project Manager

Parexel • Southport, NC

9d • Remote

About The Position

Parexel is seeking an experienced Regulatory Project Manager to partner with Global Regulatory Leads and drive global regulatory strategy and execution for vaccine development and registration programs. The role spans product development, registration, and post-marketing activities, supporting U.S. and ex-U.S. markets. The consultant will turn regulatory strategy into integrated plans, align cross-functional teams, manage complex timelines and interdependencies, and anticipate risks and opportunities to support informed decisions and successful regulatory milestones.

As a member of the Global Regulatory Science team, this highly visible role also facilitates Global Regulatory Subteam (GRST) meetings and other project forums. It establishes clear meeting objectives and agendas, documents decisions and actions, tracks follow-ups, maintains governance and communication across global and regional teams, and promotes effective team accountability. The role prepares dashboards, reports, and scenario plans for senior stakeholders and develops practical solutions to strengthen team effectiveness, process efficiency, and submission readiness.

The position is described as working from home. Technical tools include Smartsheet, Microsoft Office, PowerPoint visuals created with timeline integration tools such as One Pager or Office Timeline Pro, and Veeva Regulatory Information Management (RIM).

Requirements

• BA/BS degree in a scientific, engineering, or healthcare discipline.
• At least 7 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry, including at least 5 years in regulatory or regulatory program management.
• Proven ability to partner on regulatory strategy and lead execution across product development, including IND/BLA/MAA submissions, global registration, and post-marketing activities; previous marketing application experience is required.
• Deep understanding of U.S. and EU regulatory requirements and working knowledge of global regulations and agency expectations.
• Demonstrated success managing complex regulatory deliverables across cross-functional teams in a matrixed organization while maintaining alignment with strategic priorities.
• Hands-on eCTD experience and strong command of regulatory documentation, formatting, and submission strategy.
• Exceptional communication and influencing skills, including the ability to synthesize complex regulatory information into clear recommendations for senior leadership and global stakeholders.
• Strong judgment and agility in managing competing priorities, resource constraints, and changing program needs.
• Demonstrated ability to use project management tools and best practices to improve visibility, efficiency, cross-functional alignment, and meeting effectiveness.
• Experience facilitating cross-functional meetings, setting structured agendas, documenting decisions and actions, and maintaining meeting hygiene and team accountability in a matrixed environment.
• Commitment to continuous learning and improvement and an innovation mindset in regulatory execution and cross-functional collaboration.
• Expert skills in Smartsheet, including Regulatory Activity and Submissions Project Plans, and Microsoft Office Suite.
• Expertise creating PowerPoint visuals from timeline integration tools such as One Pager or Office Timeline Pro.
• Proficiency with Veeva Regulatory Information Management (RIM).

Nice To Haves

• Advanced degree such as an MS, PharmD, or PhD.
• PMP certification.
• Experience supporting global development programs across multiple modalities or therapeutic areas.

Responsibilities

• Partner with Global Regulatory Leads to shape and execute forward-looking, globally aligned regulatory plans across development and post-marketing.
• Translate regulatory strategy into actionable plans with milestones, critical paths, risks, and opportunities.
• Lead execution of regulatory plans, keeping operational work aligned with strategic objectives across global programs.
• Identify and propose regulatory pathways and planning scenarios aligned with global regulatory expectations and business objectives.
• Collaborate with cross-functional teams and senior leadership to drive clarity, alignment, and accountability for regulatory deliverables, timelines, and interdependencies.
• Facilitate GRST meetings and other project review forums with a focus on decision-making, risk mitigation, and regulatory execution.
• Develop and distribute meeting agendas, define objectives and discussion topics, maintain action logs, document decisions and next steps, track follow-ups to closure, and ensure meeting materials are appropriately stored and communicated.
• Maintain effective GRST governance, meeting cadence, stakeholder alignment, and communication across global and regional teams.
• Anticipate and troubleshoot regulatory project and operational challenges and implement solutions that improve team effectiveness, process efficiency, and submission readiness.
• Prepare and present strategic dashboards, reports, and scenario plans that translate regulatory progress and risks into actionable business insights.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior