Senior Regulatory Affairs Consultant - Regulatory Project Manager

Parexel is a company dedicated to improving the world's health through clinical trials and regulatory consulting. They are seeking a Senior Regulatory Affairs Consultant who will partner with Global Regulatory Leads to drive regulatory plans and manage complex development and registration programs, ensuring clarity and strategic alignment across teams.

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

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. Previous marketing application experience is required
• Deep understanding of U.S. and EU regulatory requirements with working knowledge of global 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)
• 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