Remote Regulatory Project Lead (US-Based)

Parexel International; Northern (KY); Hybrid; USD 95,000 - 150,000; Full time

Job summary

Parexel International is expanding its Regulatory Project Management team with US-based, home-based roles for experienced Regulatory Project Managers. You will oversee regulatory projects, ensure timely submissions, and collaborate with clients and FDA liaison roles.

The role requires a strong background in regulatory affairs and project management, with leadership and client relationship skills. Ideal candidates will have 3+ years in regulatory affairs project management, a scientific degree,

Qualifications

• Bachelor's degree in a scientific field; advanced degree preferred.
• Minimum of 3+ years in regulatory affairs project management.
• Demonstrated track record leading global regulatory projects and milestones.
• Deep knowledge of global regulatory requirements across therapeutic areas.
• Strong strategic thinking and ability to translate regulatory insights into business opportunities.
• Excellent project management for multiple complex projects.
• Outstanding communication and interpersonal skills across all levels.
• Proven leadership and mentoring experience.
• Adaptable to changing regulatory environments and priorities.

Responsibilities

• Oversee the operational execution of diverse regulatory projects.
• Ensure timely delivery of regulatory submissions.
• Contribute to long-term strategic planning for regulatory initiatives.
• Manage project scope and budget.
• Identify and mitigate risks while ensuring compliance.
• Collaborate with clients’ teams and internal stakeholders.
• Drive continuous improvement in regulatory processes.
• Facilitate meetings with clients and act as FDA liaison as needed.
• Build client relationships and pursue new business opportunities.

Skills

Regulatory affairs

Project management

Organizational skills

Leadership

Communication

Stakeholder management

Risk mitigation

Client relationships

Work prioritization

Regulatory strategy

Education

Bachelor's degree in a scientific field

Advanced degree (PharmD, PhD, or equivalent) preferred

Tools

MS Project

Smartsheet

Job description

Parexel International is expanding its Regulatory Project Management team with US-based, home-based roles for experienced Regulatory Project Managers. You will oversee regulatory projects, ensure timely submissions, and collaborate with clients and FDA liaison roles.

The role requires a strong background in regulatory affairs and project management, with leadership and client relationship skills. Ideal candidates will have 3+ years in regulatory affairs project management, a scientific degree,