Remote Regulatory Programs Manager

Parexel; United States; Remote; USD 110,000 - 160,000; Full time

Job summary

Parexel is seeking experienced Regulatory Project Managers in the US for home-based roles. You will oversee regulatory projects, drive submissions, and contribute to strategic planning while managing scope and budget.

Fluency in multiple languages is a plus and EST-hour availability is preferred to align with client time zones. The role emphasizes collaboration with biotech clients to ensure regulatory success and a lasting impact on patients through robust project leadership and regulatory

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 and processes across various therapeutic areas.
• Strong strategic thinking skills with the ability to translate regulatory insights into business opportunities.
• Excellent project management skills, including the ability to manage multiple complex projects simultaneously.
• Outstanding communication and interpersonal skills, with the ability to influence and collaborate effectively across all levels of the organization.
• Proven leadership abilities, including experience in mentoring and developing team members.

Responsibilities

• Oversee the operational execution of diverse regulatory projects.
• Ensure timely delivery of high-quality regulatory submissions.
• Contribute to long‑term strategic planning for the 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, as well as the FDA’s liaison, representing our sponsors as US Agent, as requested.
• Build client relationships, gain new and repeat business.

Skills

Regulatory affairs

Project management

Stakeholder management

Leadership

Communication

Risk mitigation

Time management

Language skills

Education

Bachelor's degree in a relevant field

Advanced degree preferred

Job description

Parexel is seeking experienced Regulatory Project Managers in the US for home-based roles. You will oversee regulatory projects, drive submissions, and contribute to strategic planning while managing scope and budget.

Fluency in multiple languages is a plus and EST-hour availability is preferred to align with client time zones. The role emphasizes collaboration with biotech clients to ensure regulatory success and a lasting impact on patients through robust project leadership and regulatory