Remote Regulatory Project Manager — Biotech Submissions

Parexel; Olympia (WA); Remote; USD 110,000 - 140,000; Full time

Job summary

Parexel is seeking experienced US-based Regulatory Project Managers to support biotech clients from a home-based model. You will oversee the end-to-end regulatory projects, ensure high-quality submissions, and help shape long-term regulatory strategies for multiple clients.

The role requires strong regulatory and project management skills, superb organizational abilities, and the capacity to manage timelines across global programs while communicating effectively with stakeholders and clients.

Qualifications

• Bachelor's degree in a scientific field; advanced degree preferred.
• 3+ years in regulatory affairs project management.
• Track record leading global regulatory projects and milestones.
• Knowledge of global regulatory requirements across therapeutic areas.
• Strong strategic thinking and ability to translate insights into opportunities.
• Excellent project management and multitasking abilities.
• Outstanding communication and stakeholder collaboration across all levels.
• Mentoring and developing team members.

Responsibilities

• Oversee operational execution of regulatory projects.
• Ensure timely delivery of regulatory submissions.
• Contribute to long-term regulatory strategy for clients.
• Manage project scope and budget.
• Identify and mitigate risks while ensuring compliance.
• Collaborate with client teams and internal stakeholders.
• Drive continuous improvement of regulatory processes.
• Serve as main client and internal contact, FDA liaison as requested.
• Build and maintain client relationships to generate new and repeat business.

Skills

Regulatory affairs

Project management

Stakeholder management

Global/regulatory submissions

Leadership

Time management

Risk mitigation

Client relationship management

Communication

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Parexel is seeking experienced US-based Regulatory Project Managers to support biotech clients from a home-based model. You will oversee the end-to-end regulatory projects, ensure high-quality submissions, and help shape long-term regulatory strategies for multiple clients.

The role requires strong regulatory and project management skills, superb organizational abilities, and the capacity to manage timelines across global programs while communicating effectively with stakeholders and clients.