Remote Regulatory Programs Lead

Parexel; Richmond (VA); Remote; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Vacation/Holidays/Sick Time

FSA/HSA

Work/Life Balance

401(k) Match

Pet Insurance

Job summary

Parexel seeks a Regulatory Project Manager to drive the operational execution of regulatory projects, ensuring timely submissions, maintaining compliance, and building lasting client relationships. You will collaborate across cross-functional teams to support regulatory strategy and execution from initiation through completion.

Ideal candidates have a strong regulatory affairs background, 3+ years in PM roles, and the ability to manage budgets, timelines, and risks while liaising with clients

Qualifications

• Bachelor's degree in a relevant scientific field.
• Minimum of 3+ years in a regulatory affairs project management role.
• Demonstrated track record of leading global regulatory projects and milestones.
• In-depth knowledge of global regulatory requirements across various therapeutic areas.
• Excellent project management skills managing multiple complex projects.
• Outstanding communication and interpersonal skills with the ability to influence and collaborate across all levels.
• Proven leadership abilities including mentoring and developing team members.
• Adaptability and resilience navigating changing regulatory environments.

Responsibilities

• Oversee the operational execution of diverse regulatory projects and ensure timely delivery of high-quality regulatory submissions.
• Manage project scope, budget, and timelines while maintaining strict regulatory compliance and quality standards.
• Identify and mitigate potential regulatory risks while implementing proactive problem-solving strategies.
• Collaborate closely with clients' teams, internal stakeholders, and regulatory agencies as the primary liaison and FDA representative.
• Contribute to long-term strategic planning for clients' regulatory initiatives and drive continuous improvement in regulatory processes.
• Facilitate interdisciplinary meetings, represent sponsors as US Agent when requested, and serve as the main contact for clients and internal stakeholders.
• Build and maintain strong client relationships, identify new business opportunities, and support repeat business development.
• Create and update project timelines, manage multiple complex projects simultaneously, and adapt to client-specific processes and cultures.

Skills

Regulatory submissions

Project management

Stakeholder management

Leadership

Communication

Problem solving

Education

Bachelor's degree in a relevant scientific field

Advanced degree (PharmD, PhD, or equivalent)

Job description

Parexel seeks a Regulatory Project Manager to drive the operational execution of regulatory projects, ensuring timely submissions, maintaining compliance, and building lasting client relationships. You will collaborate across cross-functional teams to support regulatory strategy and execution from initiation through completion.

Ideal candidates have a strong regulatory affairs background, 3+ years in PM roles, and the ability to manage budgets, timelines, and risks while liaising with clients