Regulatory Project Leader - Biotech Submissions (Remote)

Parexel; Denver (CO); À distance; USD 90 000 - 150 000; Plein temps

Résumé du poste

Parexel is seeking experienced, proactive US-based Regulatory Project Managers to join our growing Regulatory Project Management team. These home-based roles focus on regulatory success for biotech clients while contributing to Parexel's growth.

Ideal candidates bring a strong regulatory affairs background, solid project management skills, and a track record of successful global submissions. EST availability and client-focused collaboration across teams are valued in this role.

Qualifications

• Bachelor's degree in a relevant scientific field; advanced degree preferred.
• Minimum of 3+ years in a regulatory affairs related project management role.
• Demonstrated track record of leading global regulatory projects and achieving milestones.
• In-depth knowledge of global regulatory requirements and processes across therapeutic areas.
• Strong strategic thinking and ability to translate regulatory insights into business opportunities.
• Excellent project management skills with ability to manage multiple complex projects.

Responsabilités

• Oversee the operational execution of 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 client teams and internal stakeholders.
• Drive continuous improvement in regulatory processes and methodologies.
• Serve as main client and internal contact, and FDA liaison as needed.
• Build client relationships and foster new business.

Connaissances

Regulatory affairs

Project management

Stakeholder management

Leadership

Communication

Time management

Client relationships

Problem solving

Foreign language skills

Formation

Bachelor's degree

PharmD/PhD preferred

Description du poste

Parexel is seeking experienced, proactive US-based Regulatory Project Managers to join our growing Regulatory Project Management team. These home-based roles focus on regulatory success for biotech clients while contributing to Parexel's growth.

Ideal candidates bring a strong regulatory affairs background, solid project management skills, and a track record of successful global submissions. EST availability and client-focused collaboration across teams are valued in this role.