Remote Regulatory Project Lead

Parexel; Dover (DE); Remote; USD 90,000 - 140,000; Full time

Job summary

Parexel is seeking experienced, proactive Regulatory Project Managers based in the United States for home-based roles supporting biotech clients. You will oversee regulatory projects, ensure timely, high-quality submissions, and contribute to strategic planning while managing scope and budgets.

Ideal candidates bring a strong background in regulatory affairs and project management, excellent leadership and communication skills, and the ability to work EST hours.

Qualifications

• Bachelor's degree in a relevant scientific field.
• Minimum of 3+ years in regulatory affairs project management.
• Demonstrated track record of leading global regulatory projects and milestones.
• In-depth knowledge of global regulatory requirements across therapeutic areas.
• Strong strategic thinking and ability to translate regulatory insights into business opportunities.
• Excellent project management skills with multiple complex projects.

Responsibilities

• Oversee the 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 regulatory compliance.
• Collaborate with clients’ teams and internal stakeholders.
• Drive continuous improvement in regulatory processes and methodologies.
• Facilitate FDA liaison and represent sponsors as US Agent when requested.
• Build client relationships and pursue new and repeat business.

Skills

Regulatory affairs

Project management

Communication

Stakeholder management

Leadership

Risk mitigation

Client management

Time management

Education

Bachelor's degree in a relevant field

Advanced degree (PharmD, PhD, or equivalent) preferred

Job description

Parexel is seeking experienced, proactive Regulatory Project Managers based in the United States for home-based roles supporting biotech clients. You will oversee regulatory projects, ensure timely, high-quality submissions, and contribute to strategic planning while managing scope and budgets.

Ideal candidates bring a strong background in regulatory affairs and project management, excellent leadership and communication skills, and the ability to work EST hours.