Remote Regulatory Project Manager – Biotech Submissions

Parexel; Austin (TX); Remote; USD 100,000 - 140,000; Full time

Job summary

Parexel is seeking experienced Regulatory Project Managers based in the US to support biotech clients from a remote setting. You will oversee execution of regulatory projects, ensure timely submissions, and contribute to strategic regulatory planning for multiple campaigns.

The ideal candidate has a strong background in regulatory affairs and project management, excellent organizational and leadership skills, and a proactive approach to risk management and stakeholder engagement.

Qualifications

• Bachelor's degree in a relevant scientific field; advanced degree preferred.
• Minimum 3+ years in a regulatory affairs related project management role.
• Demonstrated track record leading global regulatory projects and achieving milestones.
• Knowledge of global regulatory requirements across therapeutic areas.
• Strong strategic thinking to translate regulatory insights into business opportunities.
• Excellent project management skills for 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.
• Collaborate with client teams and internal stakeholders.
• Drive continuous improvement in regulatory processes and methodologies.
• Serve as main client and internal contact; FDA liaison as needed.

Skills

Regulatory affairs

Project management

Leadership

Stakeholder management

Communication

Problem solving

Client relationships

Time management

Education

Bachelor's in science

Advanced degree (PharmD/PhD) preferred

Job description

Parexel is seeking experienced Regulatory Project Managers based in the US to support biotech clients from a remote setting. You will oversee execution of regulatory projects, ensure timely submissions, and contribute to strategic regulatory planning for multiple campaigns.

The ideal candidate has a strong background in regulatory affairs and project management, excellent organizational and leadership skills, and a proactive approach to risk management and stakeholder engagement.