Remote: Global Regulatory Strategy Lead (SVP)

NewAmsterdam Pharma B.V.; United States; Remote; USD 350,000 - 600,000; Full time

Benefits offered by this job

Health insurance

401(k)/retirement plan

Annual bonus

Long-term incentives

Job summary

NewAmsterdam Pharma is seeking an SVP, Head of Global Regulatory Affairs to lead the regulatory strategy across US and global markets, directing submissions, and interactions with health authorities. The role reports to the CMO and partners with Commercial, Legal, Quality, and Clinical teams to drive launch readiness and lifecycle planning.

The ideal candidate has 15+ years in regulatory affairs, with at least 10 years in senior leadership, and deep knowledge of US/EU regulatory environments,

Qualifications

• Advanced degree and 15+ years in regulatory affairs.
• Minimum 10 years in senior leadership roles.
• Experience with US and EU regulatory environments.
• Track record leading cross-functional regulatory teams.

Responsibilities

• Develop US/global regulatory strategies and submissions.
• Lead regulatory team and interface with authorities.
• Advise management on regulatory risk and lifecycle management.
• Ensure compliance with FDA, EMA, ICH guidelines.

Skills

Regulatory strategy

Leadership

FDA/EMA knowledge

Cross-functional leadership

Education

Advanced degree preferred

Tools

Regulatory databases

Electronic submissions

Job description

NewAmsterdam Pharma is seeking an SVP, Head of Global Regulatory Affairs to lead the regulatory strategy across US and global markets, directing submissions, and interactions with health authorities. The role reports to the CMO and partners with Commercial, Legal, Quality, and Clinical teams to drive launch readiness and lifecycle planning.

The ideal candidate has 15+ years in regulatory affairs, with at least 10 years in senior leadership, and deep knowledge of US/EU regulatory environments,