Senior Regulatory Affairs Consultant – Regulatory Project Manager

🕒 July 29

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 55%

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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 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 to drive clarity, alignment, and accountability • 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 and deliver strategic dashboards, reports, and scenario plans to senior stakeholders • Support regulatory milestones that enable sponsors to bring transformative vaccines to patients worldwide

🎯 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 • 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 required • Deep understanding of U.S. and EU regulatory requirements, with 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 • 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) • Advanced degree (MS, PharmD, PhD) and/or PMP certification strongly preferred • Experience supporting global development programs across multiple modalities or therapeutic areas highly desirable • Exceptional communication and influencing skills • Strong judgment and agility in managing competing priorities, resource constraints, and evolving program needs • Experience facilitating cross-functional team meetings and maintaining meeting hygiene and team accountability • Commitment to continuous learning and improvement

🏖️ Benefits

• Working from home / remote work • Equal opportunity employment