Senior Regulatory Affairs Consultant – Senior Regulatory Project Manager

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Partner strategically with Global Regulatory Leads to shape and execute 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 across global programs • Identify innovative regulatory pathways and planning scenarios • Collaborate with cross-functional teams and senior leadership on regulatory deliverables, timelines, and interdependencies • Facilitate Global Regulatory Subteam meetings and project review forums • Develop agendas, define objectives, maintain action logs, document decisions, track follow-up items, and manage meeting materials • Maintain GRST governance, meeting cadence, stakeholder alignment, and communication across global and regional teams • Anticipate and troubleshoot complex regulatory project and operational challenges • Prepare strategic dashboards, reports, and scenario plans for senior stakeholders • Translate 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 • At least 5 years in regulatory or regulatory program management • Experience across product development, including IND/BLA/MAA submissions, global registration, and post-marketing activities • Previous marketing application experience required • Deep understanding of U.S. and EU regulatory requirements and working knowledge of global regulations and agency expectations • Experience managing complex regulatory deliverables across cross-functional teams in a matrixed organization • Hands-on experience with eCTD and regulatory documentation, formatting, and submission strategy • Experience supporting global development programs across multiple modalities or therapeutic areas desirable • Exceptional communication and influencing skills • Strong judgment and agility managing competing priorities, resource constraints, and evolving program needs • Experience using project management tools and best practices to improve visibility, efficiency, alignment, and meeting effectiveness • Experience facilitating cross-functional meetings, driving structured agendas, documenting decisions and actions, and maintaining team accountability • Committed to continuous learning and improvement with an innovation mindset • Expert skills in Smartsheet and Microsoft Office Suite • Expert in creating visuals using PowerPoint generated from timeline integration tools such as One Pager and Office Timeline Pro • Proficient user of Veeva Regulatory Information Management (RIM)

🏖️ Benefits

• Working from home • Opportunity to shape global regulatory strategy and deliver breakthrough science • Work on transformative vaccines and therapies that benefit patients worldwide • Continuous learning and improvement • Innovation-focused environment