US-Based Regulatory Project Manager: Submissions & Strategy

Parexel; Boise (ID); Remote; USD 110,000 - 170,000; Full time

Job summary

Parexel is expanding its Regulatory Project Management team and seeks experienced US-based Regulatory Project Managers for home-based roles. You will oversee end-to-end regulatory projects, ensure timely submissions, and drive strategic planning for biotech clients while managing scope and budgets.

Strong leadership, communication, and risk-mitigation skills are essential, with Japanese/Chinese/Korean language skills a plus.

Qualifications

• Bachelor's degree in a relevant scientific field; advanced degree (PharmD, PhD, or equivalent) preferred.
• Minimum of 3+ years in a regulatory affairs related project management role.
• Proven track record of globally led regulatory projects and milestones.
• 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.
• Outstanding communication and interpersonal skills to influence across levels.
• Leadership experience including mentoring team members.
• Adaptability to changing regulatory environments and priorities.

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 risks while maintaining regulatory compliance.
• Collaborate with clients’ teams and internal stakeholders.
• Drive continuous improvement in regulatory processes and methodologies.
• Serve as US Agent liaison and FDA contact when requested.
• Build client relationships and seek new and repeat business.

Skills

Regulatory affairs

Project management

Regulatory submissions

Timeline management

Stakeholder management

Leadership

Communication

Client management

Education

Bachelor's degree in a relevant scientific field

Advanced degree preferred (PharmD/PhD)

Job description

Parexel is expanding its Regulatory Project Management team and seeks experienced US-based Regulatory Project Managers for home-based roles. You will oversee end-to-end regulatory projects, ensure timely submissions, and drive strategic planning for biotech clients while managing scope and budgets.

Strong leadership, communication, and risk-mitigation skills are essential, with Japanese/Chinese/Korean language skills a plus.