Remote Regulatory Project Manager – Biotech

Parexel; Augusta (ME); Teletrabalho; USD 110 000 - 150 000; Tempo integral

Resumo da oferta

Parexel is expanding its Regulatory Project Management team with US-based, remote roles. You will drive regulatory submissions and lead client projects across therapeutic areas, ensuring on-time delivery and compliance.

The ideal candidate has 3+ years in regulatory affairs project management, strong leadership, and excellent communication. EST hours flexibility enables collaboration with multiple clients and sponsors.

Qualificações

• Bachelor's degree in a scientific field; PharmD/PhD preferred.
• Minimum 3+ years in regulatory affairs project management.
• Track record of globally leading regulatory projects and milestones.
• Knowledge of global regulatory requirements across therapeutic areas.
• Strong strategic thinking translating regulatory insights into business opportunities.
• Excellent project management with multiple complex projects.
• Outstanding communication and interpersonal skills to influence across the organization.
• Leadership experience mentoring team members.
• Adaptability to changing regulatory environments and priorities.

Responsabilidades

• Oversee operational execution of diverse regulatory projects.
• Ensure timely delivery of high-quality regulatory submissions.
• Contribute to long-term strategic planning for clients’ regulatory initiatives.
• Manage project scope and budget.
• Identify and mitigate risks while maintaining regulatory compliance.
• Collaborate with clients’ teams and internal stakeholders.
• Drive continuous improvement in regulatory processes and methodologies.
• Facilitate meetings as main client and internal contact, and FDA liaison as requested.
• Build client relationships and pursue new and repeat business.

Conhecimentos

Regulatory affairs

Project management

Leadership

Stakeholder management

Communication

Risk mitigation

Client management

Problem solving

Time management

Formação académica

Bachelor's degree in a relevant field

Advanced degree (PharmD, PhD, or equivalent) preferred

Descrição da oferta de emprego

Parexel is expanding its Regulatory Project Management team with US-based, remote roles. You will drive regulatory submissions and lead client projects across therapeutic areas, ensuring on-time delivery and compliance.

The ideal candidate has 3+ years in regulatory affairs project management, strong leadership, and excellent communication. EST hours flexibility enables collaboration with multiple clients and sponsors.