Remote Regulatory Project Lead: Global Submissions

Parexel; Hartford (CT); Remote; USD 90,000 - 150,000; Full time

Benefits offered by this job

Health Insurance

401(k) with Company match

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

Pet Insurance

Job summary

Parexel is seeking a Regulatory Project Manager to join remotely, coordinating diverse regulatory projects that advance new treatments. You will ensure timely, high-quality submissions while maintaining strict compliance and building client relationships.

You will collaborate with cross-functional teams, manage timelines and budgets, and serve as a liaison with regulatory agencies. A strong background in regulatory affairs and project leadership is required.

Qualifications

• Bachelor's degree in a scientific field required.
• 3+ years in regulatory affairs project management.
• Demonstrated track record leading global regulatory projects and milestones.
• Knowledge of global regulatory requirements across therapeutic areas.
• Strong project management, organization, and prioritization skills.
• Excellent communication and stakeholder collaboration across all levels.
• Leadership experience including mentoring team members.
• Adaptability to changing regulatory environments.

Responsibilities

• Oversee operational execution of diverse regulatory projects and ensure timely regulatory submissions.
• Manage project scope, budget, and timelines with strict regulatory compliance.
• Identify regulatory risks and implement proactive risk mitigation strategies.
• Liaise between clients, internal stakeholders, and regulatory agencies (FDA as applicable).
• Contribute to strategic planning for regulatory initiatives and process improvements.
• Facilitate meetings and drive cross-functional alignment across teams.

Skills

Regulatory affairs

Project management

Stakeholder management

Regulatory submissions

Leadership

Communication

Education

Bachelor's degree in a scientific field

Advanced degree (PharmD, PhD)

Job description

Parexel is seeking a Regulatory Project Manager to join remotely, coordinating diverse regulatory projects that advance new treatments. You will ensure timely, high-quality submissions while maintaining strict compliance and building client relationships.

You will collaborate with cross-functional teams, manage timelines and budgets, and serve as a liaison with regulatory agencies. A strong background in regulatory affairs and project leadership is required.