Senior Regulatory Consultant - Regulatory Project/Program Manager

Parexel•Southport, NC

19h•Remote

About The Position

This role is for a seasoned Regulatory Project Manager at Parexel, a leading global clinical research organization dedicated to improving global health. The consultant will play a high-impact role in shaping global regulatory strategy and delivering breakthrough science, working from home. They will partner closely with Global Regulatory Leads to drive globally aligned regulatory plans, guide complex development and registration programs, and keep cross-functional teams focused on key objectives. This position requires an experienced and forward-thinking individual who can seamlessly integrate strategic thinking with operational execution across all stages of product development, registration, and post-marketing. As a key member of the Global Regulatory Science team, the consultant will lead the development and execution of proactive global regulatory plans, articulate clear milestones, surface risks and opportunities, and support timely, informed regulatory decision-making. The role demands strong leadership, agility, and strategic foresight, with accountability for driving regulatory excellence, aligning stakeholders, managing complex timelines, and anticipating challenges to ensure successful delivery of regulatory milestones for transformative mRNA medicines. The consultant will also facilitate Global Regulatory Subteam (GRST) meetings, ensuring effective structure, clear agendas, documented decisions, and timely follow-up consistent with project management best practices.

Requirements

BA/BS degree in a scientific, engineering, or healthcare discipline required.
Minimum of 7 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry, with at least 5 years in regulatory or regulatory program management.
Proven ability to partner on regulatory strategy and lead execution across all stages of product development, including IND/BLA/MAA submissions, global registration, and post-marketing activities.
Deep understanding of U.S. regulatory requirements with working knowledge of international (ex-U.S.) regulations and agency expectations.
Demonstrated success managing complex regulatory deliverables across cross-functional teams within a matrixed organization, while maintaining alignment to strategic priorities.
Hands-on experience with eCTD and a strong command of regulatory documentation, formatting, and submission strategy.
Exceptional communication and influencing skills, with the ability to synthesize complex regulatory information and translate it into clear recommendations for senior leadership and global stakeholders.
Strong judgment and agility in managing competing priorities, resource constraints, and evolving program needs with flexibility and strategic foresight.
Demonstrated ability to leverage project management tools and best practices to enhance visibility, efficiency, cross-functional alignment, and meeting effectiveness across GRSTs and project teams.
Demonstrated experience facilitating cross-functional team meetings, driving structured agendas, documenting decisions and actions, and maintaining strong meeting hygiene and team accountability in a matrixed environment.
Committed to continuous learning and improvement, bringing an innovation mindset to regulatory execution and cross-functional collaboration.
Expert skills required for Smartsheet (Regulatory Activity and Submissions Project Plans) and Microsoft Office Suite.
Expert in creating visuals using PPT generated from timeline integration tools (ie, One Pager, Office Timeline Pro, etc.).
Proficient user of Veeva Regulatory Information Management (RIM).

Nice To Haves

Advanced degree (MS, PharmD, PhD) and/or PMP certification strongly preferred.
Experience supporting global development programs across multiple modalities or therapeutic areas is highly desirable.

Responsibilities

Partner strategically with Global Regulatory Leads to shape and execute forward-looking, globally aligned regulatory plans across all stages of development and post-marketing.
Translate regulatory strategy into integrated, actionable plans with clear milestones, critical paths, risks, and opportunities to support effective planning and decision-making.
Lead the execution of regulatory plans, ensuring alignment between day-to-day operations and broader strategic objectives across global programs.
Identify and propose innovative regulatory pathways and planning scenarios that align with global regulatory expectations and business objectives.
Collaborate closely with cross-functional teams and senior leadership to drive clarity, alignment, and accountability for regulatory deliverables, timelines, and interdependencies.
Facilitate Global Regulatory Subteam (GRST) meetings and other routine and ad hoc project review forums, ensuring meetings are purpose-driven, well-structured, and focused on decision-making, risk mitigation, and regulatory execution.
Apply project management best practices for meeting management and hygiene, including developing and distributing agendas in advance, defining objectives and discussion topics, maintaining action logs, documenting key decisions and next steps, tracking follow-up items to closure, and ensuring materials are stored and communicated appropriately.
Partner with Global Regulatory Leads and cross-functional stakeholders to maintain effective GRST governance, meeting cadence, stakeholder alignment, and communication flow across global and regional teams.
Anticipate and troubleshoot complex regulatory project and operational challenges, implementing scalable solutions that strengthen team effectiveness, process efficiency, and submission readiness.
Prepare and deliver strategic dashboards, reports, and scenario plans to senior stakeholders, translating regulatory progress and risks into actionable business insights.