Remote Regulatory Project Lead | Global Submissions

Parexel; Jackson (MS); Teletrabalho; USD 100 000 - 160 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Resumo da oferta

Parexel is seeking a Regulatory Project Manager to drive operational execution of diverse regulatory projects with a focus on timely and compliant submissions for new therapies. The role involves collaborating with cross-functional teams, managing budgets and timelines, and serving as a liaison to clients and regulatory agencies.

Ideal candidates will have a strong regulatory affairs background, at least 3 years in related project management, and excellent communication skills.

Qualificações

• Bachelor's degree in a relevant scientific field required.
• Minimum 3+ years in regulatory affairs project management.
• Experience leading global regulatory projects and achieving milestones.
• Knowledge of global regulatory requirements across therapeutic areas.
• Excellent communication and interpersonal skills; ability to influence at all levels.

Responsabilidades

• Oversee operational execution of diverse regulatory projects and ensure timely submissions.
• Manage project scope, budget, and timelines while maintaining compliance and quality.
• Identify and mitigate regulatory risks with proactive problem-solving.
• Serve as primary liaison between clients, internal stakeholders, and regulatory agencies (FDA representative as needed).
• Contribute to long-term regulatory strategy and drive process improvements.
• Facilitate interdisciplinary meetings and manage client relationships; explore new business opportunities.

Conhecimentos

Regulatory affairs

Project management

Stakeholder management

FDA liaison

Cross-functional collaboration

Formação académica

Bachelor's degree in a relevant scientific field

Advanced degree (PharmD, PhD, or equivalent)

Descrição da oferta de emprego

Parexel is seeking a Regulatory Project Manager to drive operational execution of diverse regulatory projects with a focus on timely and compliant submissions for new therapies. The role involves collaborating with cross-functional teams, managing budgets and timelines, and serving as a liaison to clients and regulatory agencies.

Ideal candidates will have a strong regulatory affairs background, at least 3 years in related project management, and excellent communication skills.