Remote Regulatory Project Manager — Biotech Submissions

Parexel; Carson City (NV); Remote; USD 110,000 - 170,000; Full time

Job summary

Parexel is seeking experienced Regulatory Project Managers based in the US to drive regulatory success for biotech clients from a home-based role. You will oversee diverse regulatory projects, ensure on-time, high-quality submissions, and contribute to strategic planning while managing scope and budget.

The ideal candidate has a strong regulatory background, excellent organizational and leadership skills, and a proactive, client-focused approach to risk management.

Qualifications

• Bachelor’s degree in a scientific field is required; advanced degrees preferred.
• Minimum 3+ years in a regulatory affairs related project management role.
• Proven track record leading global regulatory projects and meeting 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 and ability to manage 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 risks while maintaining regulatory compliance.
• Collaborate closely with clients’ teams and internal stakeholders.
• Drive continuous improvement in regulatory processes and methodologies.
• Serve as the main client and internal contact, and act as FDA liaison when requested.
• Build client relationships and pursue new and repeat business.

Skills

Regulatory affairs

Project management

Stakeholder management

Leadership

Communication

Prioritization

Client focus

Problem solving

Education

Bachelor’s degree in a relevant scientific field

Advanced degree (PharmD, PhD, or equivalent) preferred

Job description

Parexel is seeking experienced Regulatory Project Managers based in the US to drive regulatory success for biotech clients from a home-based role. You will oversee diverse regulatory projects, ensure on-time, high-quality submissions, and contribute to strategic planning while managing scope and budget.

The ideal candidate has a strong regulatory background, excellent organizational and leadership skills, and a proactive, client-focused approach to risk management.