Remote Regulatory Project Lead – Biotech Submissions

Parexel; Little Rock (AR); Remote; USD 90,000 - 120,000; Full time

Job summary

Parexel is seeking experienced Regulatory Project Managers for US-based, home-based roles. You will guide regulatory programs for biotech clients, ensuring on-time, compliant submissions while engaging multiple stakeholders and FDA liaison duties.

Ideal candidates bring 3+ years in regulatory affairs project management, strong leadership, and a track record of global project delivery; EST alignment is preferred for collaboration across time zones.

Qualifications

• Bachelor's degree in a relevant scientific field; advanced degree preferred.
• Minimum 3+ years in a regulatory affairs project management role.
• Track record leading global regulatory projects and milestones.
• Knowledge of global regulatory requirements across therapeutic areas.
• Translate regulatory insights into business opportunities.
• Manage multiple complex projects and strong interpersonal skills.

Responsibilities

• Oversee the operational execution of regulatory projects.
• Ensure timely delivery of high-quality regulatory submissions.
• Contribute to long-term strategic planning for clients’ regulatory initiatives.
• Be responsible for managing 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.
• Facilitate interdisciplinary meetings as main client/internal contact and FDA liaison as requested.
• Build client relationships and pursue new and repeat business.

Skills

Regulatory affairs

Project management

Regulatory submissions

Timeline management

Stakeholder management

Communication

Leadership

Problem solving

Education

Bachelor's degree in science

Advanced degree preferred (PharmD/PhD)

Job description

Parexel is seeking experienced Regulatory Project Managers for US-based, home-based roles. You will guide regulatory programs for biotech clients, ensuring on-time, compliant submissions while engaging multiple stakeholders and FDA liaison duties.

Ideal candidates bring 3+ years in regulatory affairs project management, strong leadership, and a track record of global project delivery; EST alignment is preferred for collaboration across time zones.