Global Regulatory Affairs Director – Submissions & Strategy

KMR Search Group; United States; Presencial; USD 180 000 - 260 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, Dental, Vision starting Day 1

401k matching up to 10%

Stock options grant

Relocation assistance

Resumo da oferta

KMR Search Group is seeking a Director Of Regulatory Affairs in the United States to lead global regulatory activities for clinical programs. The role focuses on IND/CTA and BLA submissions, providing strategic and operational leadership to project teams.

Responsibilities include liaising with FDA and health authorities, developing regulatory strategies, and ensuring timely regulatory submissions while supporting ongoing clinical activities.

Qualificações

• Minimum of 10 years in the pharmaceutical industry with at least 5 years in regulatory affairs.
• MD, Ph.D. or PharmD required.
• Experience leading IND/CTA and BLA submissions.

Responsabilidades

• Provide leadership on global clinical regulatory activities and filings.
• Lead regulatory strategy and collaboration with senior management for assigned programs.
• Liaise with FDA and other health authorities for assigned programs and manage licensing applications (BLA/MAA).
• Support ongoing clinical activities and ensure regulatory commitments are met within timelines.

Conhecimentos

Regulatory leadership

Strategic thinking

Project management

Formação académica

MD/PhD/PharmD

Descrição da oferta de emprego

KMR Search Group is seeking a Director Of Regulatory Affairs in the United States to lead global regulatory activities for clinical programs. The role focuses on IND/CTA and BLA submissions, providing strategic and operational leadership to project teams.

Responsibilities include liaising with FDA and health authorities, developing regulatory strategies, and ensuring timely regulatory submissions while supporting ongoing clinical activities.