Remote Regulatory Program Manager

Parexel; Indianapolis (IN); Remote; USD 90,000 - 150,000; Full time

Job summary

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

Strong leadership, communication, and stakeholder management are essential, with foreign language skills a plus. Ideal candidates have 3+ years in regulatory affairs project management and a track record of global submissions across therapies.

Qualifications

• Bachelor's degree in a 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 leading global regulatory projects and achieving 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.

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 main client and internal contact and FDA liaison where applicable.
• Build client relationships and pursue new and repeat business.

Skills

Regulatory affairs

Project management

Leadership

Stakeholder management

Communication

Time management

Problem solving

Client relationships

Risk mitigiation

Foreign language

Education

Bachelor's degree in science

PharmD/PhD or equivalent

Job description

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

Strong leadership, communication, and stakeholder management are essential, with foreign language skills a plus. Ideal candidates have 3+ years in regulatory affairs project management and a track record of global submissions across therapies.