Remote Regulatory Project Leader

Parexel; Lincoln (NE); Remote; USD 110,000 - 165,000; Full time

Job summary

Parexel is seeking experienced Regulatory Project Managers based in the US for home-based roles. You will oversee regulatory projects and ensure timely submissions for biotech clients.

Ideal candidates have 3+ years in regulatory affairs project management, excellent organization, leadership and stakeholder management skills, and the ability to work EST hours. This client-focused position offers growth within a growing team and the chance to impact global healthcare through effective strategy

Qualifications

• Bachelor's degree in a relevant scientific field; PharmD/PhD preferred.
• Minimum 3+ years in regulatory affairs project management.
• Proven track record leading global regulatory projects and milestones.
• In-depth knowledge of global regulatory requirements across various therapeutic areas.
• Strong strategic thinking and ability to translate regulatory insights into business opportunities.
• Excellent leadership, communication, and stakeholder management skills.
• Ability to adapt to client-specific processes and timelines.
• EST time-zone availability or ability to work EST hours.

Responsibilities

• Oversee operational execution of diverse regulatory projects.
• Ensure timely delivery of high-quality regulatory submissions.
• Support long-term strategic planning for client regulatory initiatives.
• Manage project scope and budget while mitigating risks.
• Coordinate with client teams and internal stakeholders.
• Represent sponsors as US Agent and FDA liaison when required.
• Drive continuous improvement in regulatory processes.
• Build and maintain strong client relationships.

Skills

Regulatory affairs

Project management

Regulatory submissions

Stakeholder management

Cross-functional collaboration

Education

Bachelor's degree in a relevant scientific field

Advanced degree (PharmD, PhD, or equivalent)

Job description

Parexel is seeking experienced Regulatory Project Managers based in the US for home-based roles. You will oversee regulatory projects and ensure timely submissions for biotech clients.

Ideal candidates have 3+ years in regulatory affairs project management, excellent organization, leadership and stakeholder management skills, and the ability to work EST hours. This client-focused position offers growth within a growing team and the chance to impact global healthcare through effective strategy