Remote Regulatory Program Lead

Parexel; Trenton (NJ); Remote; USD 110,000 - 170,000; Full time

Job summary

Parexel is expanding its Regulatory Project Management team with experienced US-based professionals. These home-based roles focus on driving regulatory success for biotech clients while supporting company growth.

You will oversee regulatory projects, ensure timely submissions, and help shape long-term regulatory strategies across diverse therapeutic areas, collaborating closely with clients and internal teams in an environment that values proactive problem-solving and strong stakeholder

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.
• Demonstrated track record of successfully leading global regulatory projects and achieving key milestones.
• In-depth knowledge of global regulatory requirements across various therapeutic areas.
• Strong strategic thinking with ability to translate regulatory insights into opportunities.
• Excellent project management skills with 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 with clients’ teams and internal stakeholders.
• Drive continuous improvement in regulatory processes and methodologies.
• Serve as the main client and internal contact, and liaise with FDA as requested.
• Build client relationships and contribute to new and repeat business.

Skills

Regulatory affairs

Project management

Organizational skills

Leadership

Stakeholder management

Communication

Risk mitigation

Client management

Time management

Cross-functional collaboration

Education

Bachelor’s degree in a life sciences field

Advanced degree (PharmD/PhD) preferred

Job description

Parexel is expanding its Regulatory Project Management team with experienced US-based professionals. These home-based roles focus on driving regulatory success for biotech clients while supporting company growth.

You will oversee regulatory projects, ensure timely submissions, and help shape long-term regulatory strategies across diverse therapeutic areas, collaborating closely with clients and internal teams in an environment that values proactive problem-solving and strong stakeholder