Remote Regulatory Project Manager (Biotech)

Parexel; Montpelier (VT); Remote; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Parexel is seeking experienced US-based Regulatory Project Managers for home-based roles. You will oversee diverse regulatory projects, ensuring timely, high-quality submissions and contributing to strategic planning for biotech clients.

Ideal candidates bring strong leadership, stakeholder management, and regulatory submissions expertise, with a proactive, client-focused approach and ability to work EST hours in a remote environment.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory affairs

Project management

Stakeholder mgmt

Timeline planning

Regulatory submissions

Leadership

Communication

Ausbildung

Bachelor's in a relevant scientific field

Advanced degree (PharmD/PhD) preferred

Jobbeschreibung

Parexel is seeking experienced US-based Regulatory Project Managers for home-based roles. You will oversee diverse regulatory projects, ensuring timely, high-quality submissions and contributing to strategic planning for biotech clients.

Ideal candidates bring strong leadership, stakeholder management, and regulatory submissions expertise, with a proactive, client-focused approach and ability to work EST hours in a remote environment.