Global Regulatory Affairs Director - Strategy & Submissions

OpenKrill; United States; A distancia; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Pulmovant is seeking a Senior Director of Regulatory Affairs to lead global regulatory strategy and drive submissions for development programs. You will coordinate cross-functional teams, manage timelines, and liaise with health authorities across multiple regions to ensure compliance and timely approvals.

The role requires extensive FDA experience and a track record in NDA/BLA submissions, with leadership across US/EU/Japan regulatory activities and collaboration with partners and CROs.

Formación

• Education and experience in regulatory affairs with NDA/MAA submissions.
• Experience leading global regulatory strategies across US/EU/Japan.
• Ability to coordinate with CROs, internal teams, and health authorities.

Responsabilidades

• Provide global regulatory strategy and support from development through approval.
• Manage submissions (IND/CTA, BLA/NDA/MAA) to health authorities.
• Lead interactions with FDA and other regulatory bodies and partners.

Conocimientos

Regulatory strategy

FDA interactions

Regulatory submissions

Cross-functional leadership

Educación

Bachelor's degree in a scientific field

Master's degree in a scientific field

PhD/PharmD in scientific field

Descripción del empleo

Pulmovant is seeking a Senior Director of Regulatory Affairs to lead global regulatory strategy and drive submissions for development programs. You will coordinate cross-functional teams, manage timelines, and liaise with health authorities across multiple regions to ensure compliance and timely approvals.

The role requires extensive FDA experience and a track record in NDA/BLA submissions, with leadership across US/EU/Japan regulatory activities and collaboration with partners and CROs.