Regulatory Project Manager

Overview

Parexel is seeking a Regulatory Project Manager to drive the operational execution of regulatory projects, ensuring timely, high-quality regulatory submissions and strict compliance, and serving as the primary liaison between clients, internal stakeholders and regulatory agencies.

What you'll do

• Oversee the operational execution of diverse regulatory projects and ensure timely delivery of high-quality regulatory submissions
• Manage project scope, budget, and timelines while maintaining strict regulatory compliance and quality standards
• Identify and mitigate potential regulatory risks while implementing proactive problem-solving strategies
• Collaborate closely with clients' teams, internal stakeholders, and regulatory agencies as the primary liaison and FDA representative
• Contribute to long-term strategic planning for clients' regulatory initiatives and drive continuous improvement in regulatory processes
• Facilitate interdisciplinary meetings, represent sponsors as US Agent when requested, and serve as the main contact for clients and internal stakeholders
• Build and maintain strong client relationships, identify new business opportunities, and support repeat business development
• Create and update project timelines, manage multiple complex projects simultaneously, and adapt to client-specific processes and cultures

What you'll need

• Bachelor's degree in a relevant scientific field
• Minimum of 3+ years in a regulatory affairs related project management role
• Demonstrated 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
• Excellent project management skills, including the ability to manage multiple complex projects simultaneously
• Outstanding communication and interpersonal skills with the ability to influence and collaborate effectively across all levels of the organization
• Proven leadership abilities, including experience in mentoring and developing team members
• Adaptability and resilience in navigating changing regulatory environments and organizational priorities
• Strong background in regulatory affairs and project management with proven track record of successful regulatory submissions
• Excellent organizational, leadership, communication, and stakeholder management skills
• Strategic thinking abilities with the capacity to translate regulatory insights into business opportunities
• Ability to adapt to client-specific processes and cultures while maintaining prompt communication and strong work prioritization
• Proactive approach to problem-solving, risk mitigation, and continuous process improvement
• Excellent customer service skills and the ability to influence and collaborate effectively across all organizational levels

Nice to have

• Advanced degree (PharmD, PhD, or equivalent)
• Foreign language skills with fluency in Japanese, Chinese, or Korean
• Experience working in EST time zone or demonstrated ability to work EST hours from other US time zones

Details

• Remote position in the United States
• Ideally located in EST; consideration given to experienced candidates in other US time zones who can work EST hours