Remote Regulatory Submissions Lead (US-based)

Parexel; Cheyenne (WY); Remote; USD 120,000 - 160,000; Full time

Job summary

Parexel is expanding its Regulatory Project Management team with experienced, proactive US-based Regulatory Project Managers. These home-based roles drive regulatory success for biotech clients while supporting company growth.

You will oversee project execution, ensure timely submissions, and contribute to long-term regulatory strategies, managing scope and budget, mitigating risks, and coordinating with client teams and internal stakeholders.

Qualifications

• Bachelor’s degree in a scientific field is required.
• Advanced degree (PharmD, PhD, or equivalent) is preferred.
• Minimum several years of regulatory affairs project management experience.

Responsibilities

• Oversee the operational execution of regulatory projects.
• Ensure timely delivery of high-quality regulatory submissions.
• Collaborate with clients’ teams and internal stakeholders.
• Manage project scope and budget; identify and mitigate risks.
• Drive continuous improvement in regulatory processes and methodologies.
• Serve as the main client and internal contact and FDA liaison as requested.
• Build client relationships and contribute to new and repeat business.

Skills

Regulatory affairs

Project management

Organizational skills

Leadership

Stakeholder management

Communication

Client-facing

Risk mitigation

Foreign language (Japanese/Chinese/Kor

Education

Bachelor's degree in a relevant scientific field

Advanced degree (PharmD, PhD, or equivalent) preferred

Job description

Parexel is expanding its Regulatory Project Management team with experienced, proactive US-based Regulatory Project Managers. These home-based roles drive regulatory success for biotech clients while supporting company growth.

You will oversee project execution, ensure timely submissions, and contribute to long-term regulatory strategies, managing scope and budget, mitigating risks, and coordinating with client teams and internal stakeholders.