Remote Regulatory Project Manager: Global Submissions

Parexel; Salt Lake City (UT); Remote; USD 90,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Regulatory Project Manager to join our team remotely. You will drive execution of global regulatory projects, ensuring timely submissions, compliance, and strong client relationships across cross-functional teams.

Ideal candidates have a track record in regulatory affairs and project management, with ability to manage scope, timelines, budgets, and risks while collaborating with FDA and other agencies. EST timezone experience is preferred.

Qualifications

• Bachelor's degree in a relevant scientific field.
• Minimum 3+ years in regulatory affairs related project management.
• Demonstrated track record leading global regulatory projects.
• Knowledge of global regulatory requirements across therapeutic areas.
• Excellent communication and interpersonal skills.

Responsibilities

• Oversee operational execution of regulatory projects and timely submissions.
• Manage scope, budget, and timelines while ensuring compliance.
• Identify regulatory risks and implement mitigation strategies.
• Serve as liaison between clients, internal teams and regulatory agencies.
• Contribute to strategic planning for regulatory initiatives and process improvements.

Skills

Regulatory affairs

Project management

Stakeholder management

Leadership

Communication

Global regulatory

Education

Bachelor's degree in a relevant scientific field

Job description

Parexel is seeking a Regulatory Project Manager to join our team remotely. You will drive execution of global regulatory projects, ensuring timely submissions, compliance, and strong client relationships across cross-functional teams.

Ideal candidates have a track record in regulatory affairs and project management, with ability to manage scope, timelines, budgets, and risks while collaborating with FDA and other agencies. EST timezone experience is preferred.