Remote Regulatory Program Manager

Parexel; Madison (WI); Remote; USD 95,000 - 150,000; Full time

Job summary

Parexel is seeking experienced Regulatory Project Managers based in the US to drive regulatory success for biotech clients. These home-based roles involve overseeing diverse projects, ensuring timely submissions, and contributing to strategic planning while managing scope and budget.

The ideal candidate will have a strong regulatory and project management background, excellent communication, and leadership skills, plus the ability to adapt to client-specific processes and cultures.

Qualifications

• Bachelor's degree in a relevant scientific field; PharmD/PhD preferred.
• Minimum of 3+ years in regulatory affairs project management.
• Proven track record leading global regulatory projects and milestones.
• In-depth knowledge of global regulatory requirements across therapeutic areas.
• Strong strategic thinking translating regulatory insights into business opportunities.
• Excellent project management across multiple complex projects.
• Outstanding communication and interpersonal skills, with the ability to influence and collaborate.
• Proven leadership abilities, including mentoring and developing team members.
• Adaptability and resilience in navigating changing regulatory environments and priorities.

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.
• Be responsible for managing project scope and budget.
• Identify and mitigate potential risks while maintaining strict regulatory compliance.
• Collaborate closely with the clients’ teams and internal stakeholders.
• Drive continuous improvement in regulatory processes and methodologies.
• Facilitate interdisciplinary meetings as the main client and internal contact, and serve as FDA liaison as US Agent.
• Build client relationships and gain new and repeat business.

Skills

Regulatory affairs

Project management

Leadership

Stakeholder management

Communication

Risk mitigation

Client relationships

Prioritization

Language skills

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. These home-based roles involve overseeing diverse projects, ensuring timely submissions, and contributing to strategic planning while managing scope and budget.

The ideal candidate will have a strong regulatory and project management background, excellent communication, and leadership skills, plus the ability to adapt to client-specific processes and cultures.