Remote Senior Director, Regulatory Affairs – Strategy

Pulmovant; United States; A distancia; USD 260.000 - 380.000; Jornada completa

Descripción de la vacante

Pulmovant seeks a Senior Director of Regulatory Affairs to lead global regulatory strategy and ensure timely, compliant submissions for pulmonary programs. You will manage interactions with the FDA and other global health authorities, oversee NDA/MAA submissions, and guide cross-functional teams through development to approval.

The role demands extensive regulatory leadership, deep experience with US and international requirements, and a proactive approach to risk management and dossier

Formación

• 15+ years of regulatory affairs experience with leadership roles.
• Experience leading NDA submissions and interactions with health authorities.
• Experience with global regulatory requirements (FDA, EMA, PMDA, ICH).

Responsabilidades

• Provide global regulatory strategy and leadership across development programs.
• Lead submissions to health authorities (IND/CTA, NDA/BLA) and interactions with regulators.
• Coordinate with CROs and internal stakeholders to ensure compliant filings and timelines.
• Monitor regulatory developments and advise on potential impact to programs.
• Mentor and supervise junior regulatory staff and cross-functional teams.

Conocimientos

Regulatory strategy

FDA experience

Cross-functional leadership

Clinical development

GxP awareness

Educación

BS in scientific field

MS in scientific field

PhD/PharmD in scientific field

Descripción del empleo

Pulmovant seeks a Senior Director of Regulatory Affairs to lead global regulatory strategy and ensure timely, compliant submissions for pulmonary programs. You will manage interactions with the FDA and other global health authorities, oversee NDA/MAA submissions, and guide cross-functional teams through development to approval.

The role demands extensive regulatory leadership, deep experience with US and international requirements, and a proactive approach to risk management and dossier