Remote Regulatory Project Manager — Biotech Growth

Parexel; Oklahoma City (OK); A distancia; USD 110.000 - 165.000; Jornada completa

Descripción de la vacante

Parexel is seeking experienced Regulatory Project Managers based in the United States for home-based roles guiding regulatory submissions for biotech clients. You will oversee execution, ensure timely delivery, and collaborate with client teams and internal stakeholders.

Ideal candidates have 3+ years in regulatory affairs project management, a strong track record of global submissions, and excellent leadership and communication skills.

Formación

• 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.

Responsabilidades

• 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

Conocimientos

Regulatory affairs

Project management

Stakeholder management

Regulatory submissions

Timeline management

Risk mitigation

Client relationship

Leadership

Communication

Regulatory processes

Cross-functional collaboration

Prioritization

EST hours availability

Educación

Bachelor's degree in a relevant scientific field

Advanced degree (PharmD, PhD, or equivalent) preferred

Descripción del empleo

Parexel is seeking experienced Regulatory Project Managers based in the United States for home-based roles guiding regulatory submissions for biotech clients. You will oversee execution, ensure timely delivery, and collaborate with client teams and internal stakeholders.

Ideal candidates have 3+ years in regulatory affairs project management, a strong track record of global submissions, and excellent leadership and communication skills.