Regulatory Project Manager

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart(R).

About the Role

We are seeking a Regulatory Project Manager to join our team in a remote capacity. As a Regulatory Project Manager, you will drive the operational execution of diverse regulatory projects that advance new treatments for patients. This position plays a key role in ensuring timely delivery of high-quality regulatory submissions, maintaining strict compliance, and building lasting client relationships. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to regulatory strategy and execution from project initiation through successful completion.

Responsibilities include overseeing project scope and budget, managing timelines and deliverables, identifying and mitigating regulatory risks, and serving as the primary liaison between clients, internal stakeholders, and regulatory agencies. With diverse teams and continuous learning opportunities, the Regulatory Project Manager can explore career paths and expand skills across global regulatory affairs.

• 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

Candidate Profile

You'll thrive in this role if you bring:

• 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

Required Qualifications

• 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…