Remote Regulatory Project Leader — Biotech Submissions

Parexel; Juneau (AK); À distance; USD 110 000 - 150 000; Plein temps

Résumé du poste

Parexel is seeking experienced Regulatory Project Managers based in the United States to drive regulatory submissions and program delivery for biotech clients. These remote roles involve coordinating diverse projects, guiding timelines, budgets, and regulatory strategies, and acting as the main client and internal contact.

Ideal candidates bring a strong background in regulatory affairs and project management, excellent communication, and the ability to navigate global regulatory requirements.

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.

Responsabilités

• 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

Connaissances

Regulatory affairs

Project management

Stakeholder management

Leadership

Communication

Risk mitigation

Client management

Regulatory submissions

Timeline management

Problem solving

Formation

Bachelor's degree in a relevant scientific field

Advanced degree (PharmD, PhD, or equivalent)

Description du poste

Parexel is seeking experienced Regulatory Project Managers based in the United States to drive regulatory submissions and program delivery for biotech clients. These remote roles involve coordinating diverse projects, guiding timelines, budgets, and regulatory strategies, and acting as the main client and internal contact.

Ideal candidates bring a strong background in regulatory affairs and project management, excellent communication, and the ability to navigate global regulatory requirements.