Remote SVP, Global Regulatory Affairs & Strategy

Regulatory Jobs; United States; Remote; USD 300.000 - 450.000; Vollzeit

Benefits dieser Stelle

Executive bonus program

Long-term incentives

Zusammenfassung

NewAmsterdam Pharma seeks an SVP, Head of Global Regulatory Affairs to lead regulatory strategy across the US, EU, and other regions, guiding development from preclinical through post-approval and lifecycle management. This role reports to the Chief Medical Officer and drives interactions with FDA, EMA, and other authorities, shaping policies and timelines.

You will build and lead a regulatory team, align with Commercial, Legal, Quality and PV, and ensure compliant labeling, post-marketing

Qualifikationen

• Advanced degree preferred in a relevant field.
• 15+ years regulatory experience, including 10+ years in a senior leadership role.
• Proven ability to lead regulatory teams and external partners.
• Strong knowledge of US, EU, and global regulatory environments for drug development.
• Experience with late-stage, launch and post-approval activities.

Aufgaben

• Develop US and global regulatory strategies aligned with business objectives.
• Provide leadership and direction to the regulatory team and senior management.
• Lead regulatory interactions with FDA, EMA and other authorities; primary liaison on day-to-day interactions.
• Oversee regulatory submissions, labeling updates, and post-approval commitments.
• Coordinate with Commercial, Medical Affairs, Legal/Compliance, Quality and PV to ensure launch readiness.
• Maintain up-to-date knowledge of regulatory guidelines and industry standards.

Kenntnisse

Strategic leadership

Regulatory strategy

Team leadership

Cross-functional collaboration

Regulatory risk management

Project management

Ausbildung

Advanced degree

Jobbeschreibung

NewAmsterdam Pharma seeks an SVP, Head of Global Regulatory Affairs to lead regulatory strategy across the US, EU, and other regions, guiding development from preclinical through post-approval and lifecycle management. This role reports to the Chief Medical Officer and drives interactions with FDA, EMA, and other authorities, shaping policies and timelines.

You will build and lead a regulatory team, align with Commercial, Legal, Quality and PV, and ensure compliant labeling, post-marketing