Regulatory Project Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ 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

• Oversee operational execution of diverse regulatory projects • Ensure timely delivery of high-quality regulatory submissions • Contribute to long-term strategic planning for clients’ regulatory initiatives • Manage project scope and budget • Identify and mitigate potential risks while maintaining strict regulatory compliance • Collaborate with client teams and internal stakeholders • Drive continuous improvement in regulatory processes and methodologies • Facilitate interdisciplinary meetings as the main client and internal contact and FDA liaison, representing sponsors as US Agent when requested • Build client relationships and gain new and repeat business • Partner with multiple clients and contribute to their regulatory programs

🎯 Requirements

• US-based Regulatory Project Manager • Strong background in regulatory affairs and project management • Excellent organizational skills • Proven track record of successful regulatory submissions • Previous experience creating and updating project timelines • Excellent leadership, communication, stakeholder management, and customer service skills • Ability to adapt to client-specific processes and culture • Prompt communication and strong understanding of work prioritization and urgencies • Proactive problem-solving and risk mitigation • Fluency in Japanese, Chinese, or Korean highly preferred; foreign language skills are a plus • Bachelor's degree in a relevant scientific field required; advanced degree (PharmD, PhD, or equivalent) preferred • Minimum of 3+ years in a regulatory affairs-related project management role • Track record of successfully leading global regulatory projects and achieving key milestones • In-depth knowledge of global regulatory requirements and processes across various therapeutic areas • Strategic thinking and ability to translate regulatory insights into business opportunities • Ability to manage multiple complex projects simultaneously • Ability to influence and collaborate effectively across all organizational levels • Leadership experience, including mentoring and developing team members • Adaptability and resilience in changing regulatory environments and organizational priorities • Ability to work EST hours; candidates in other US time zones may be considered

🏖️ Benefits

• Home-based/remote work • Potential for career advancement