Remote Regulatory Project Manager (Biotech)

Parexel; Lansing (MI); Remote; USD 100,000 - 150,000; Full time

Job summary

Parexel is actively seeking experienced US-based Regulatory Project Managers to join our Regulatory Project Management team, in home-based roles that support biotech clients and our growth agenda.

You will oversee operational execution of diverse regulatory projects, ensure timely high-quality submissions, manage scope and budget, and mitigate risks while collaborating with client teams and internal stakeholders. EST-friendly hours are preferred.

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.
• Adaptability and resilience in navigating changing regulatory environments and organizational priorities.

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

Leadership

Stakeholder management

Communication

Organizational skills

Risk management

Client relationship management

Multitasking

Education

Bachelor's degree in a relevant scientific field

PharmD / PhD or equivalent advanced degree preferred

Tools

MS Project

Veeva Vault

Regulatory submissions software

Job description

Parexel is actively seeking experienced US-based Regulatory Project Managers to join our Regulatory Project Management team, in home-based roles that support biotech clients and our growth agenda.

You will oversee operational execution of diverse regulatory projects, ensure timely high-quality submissions, manage scope and budget, and mitigate risks while collaborating with client teams and internal stakeholders. EST-friendly hours are preferred.