Strategic Regulatory Director — Regenerative Medicine & Biologics

IQVIA Inc; Washington (District of Columbia); Presencial; USD 129.000 - 359.000; Tempo integral

Resumo da vaga

IQVIA MedTech seeks a Director of Regulatory Affairs to lead regulatory strategy and submissions for client programs across medical devices, drugs, biologics, and combinations. You will drive regulatory planning, interact with agencies, and mentor junior staff while managing project timelines and budgets.

The role requires five+ years in Regulatory Affairs with FDA oversight experience, strong technical writing, and an ability to lead cross-functional teams and client relations in a dynamic

Qualificações

• Education: Bachelor's in a scientific, engineering, regulatory field; MS/PhD preferred.
• Minimum five years in Regulatory Affairs related to FDA oversight of medical products.
• Understanding of FDA regulations, clinical development and data analysis.
• Regulatory landscape fluency (FDA, ICH, ISO) and ability to communicate strategy.

Responsabilidades

• Develop and execute regulatory services for client companies and regulatory submissions.
• Regulatory Agency Interactions (e.g., INTERACT, PDUFA meetings, Q-Submissions).
• Regulatory Strategy, Analysis & Development Product Classification and Jurisdiction.
• Manage Regulatory Affairs staff and ensure timely completion of projects.
• Lead business development to secure new clients and projects.
• Develop project and departmental budgets and timelines.
• Collaborate with other departments and external partners.

Conhecimentos

Regulatory Affairs

FDA regulatory

Project management

Leadership

Technical writing

Communication skills

Regulatory strategy

Formação

Bachelor's degree in a scientific, engineering, or regulatory discipline

MS or PhD preferred

Ferramentas

MS Office

Excel

Word

PowerPoint

Descrição da vaga

IQVIA MedTech seeks a Director of Regulatory Affairs to lead regulatory strategy and submissions for client programs across medical devices, drugs, biologics, and combinations. You will drive regulatory planning, interact with agencies, and mentor junior staff while managing project timelines and budgets.

The role requires five+ years in Regulatory Affairs with FDA oversight experience, strong technical writing, and an ability to lead cross-functional teams and client relations in a dynamic