Remote Regulatory Program Lead | Global Submissions

Regulatory Jobs; United States; A distancia; USD 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health Insurance

Tuition Reimbursement

Vacation/Holidays/Sick Time

Flexible Spending Account

Work/Life Balance

401(k) with Company match

Pet Insurance

Descripción de la vacante

Parexel is seeking a Regulatory Project Manager to join our team in a remote capacity. You will drive the operational execution of diverse regulatory projects, ensuring timely regulatory submissions and strict compliance while building lasting client relationships.

You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to regulatory strategy from initiation through completion.

Formación

• Bachelor's degree in a relevant scientific field.
• Minimum 3+ years in a regulatory affairs related project management role.
• Led global regulatory projects and achieved milestones.
• In-depth knowledge of global regulatory requirements across therapeutic areas.
• Excellent project management, communication and stakeholder skills.
• Proven leadership abilities including mentorship.

Responsabilidades

• Oversee the operational execution of regulatory projects and submissions.
• Manage scope, budget, and timelines while ensuring compliance.
• Identify and mitigate regulatory risks with proactive solutions.
• Liaise between clients, internal stakeholders and regulatory agencies.
• Contribute to long-term regulatory strategy and process improvements.
• Lead interdisciplinary meetings and act as US Agent when requested.
• Build client relationships and support repeat business.
• Create and update timelines across multiple complex projects.

Conocimientos

Regulatory affairs

Project management

Leadership

Stakeholder management

Communication skills

Educación

Bachelor's degree

Advanced degree

Descripción del empleo

Parexel is seeking a Regulatory Project Manager to join our team in a remote capacity. You will drive the operational execution of diverse regulatory projects, ensuring timely regulatory submissions and strict compliance while building lasting client relationships.

You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to regulatory strategy from initiation through completion.