Remote Global Regulatory SVP — Strategy & Launch Lead

NewAmsterdam Pharma Company; Northern (KY); Hybrid; USD 250,000 - 380,000; Full time

Benefits offered by this job

Health insurance

Dental and vision coverage

Retirement plans

Annual bonus

Long-term incentives

Job summary

NewAmsterdam Pharma Company is seeking a Senior Vice President, Head of Global Regulatory Affairs to lead regulatory strategy across global submissions for late-stage programs and post-approval lifecycle management. The role is remote in the USA and reports to the Chief Medical Officer.

You will guide development teams, manage interactions with FDA, EMA, and other authorities, and build a high-performing regulatory function while coordinating with Commercial, Legal, and Quality to ensure timely

Qualifications

• 15+ years of regulatory experience with at least 10 years in a senior leadership role.
• Proven ability to lead regulatory teams and external partners.
• Extensive knowledge of US and EU drug development regulations.
• Experience directing late-stage development, launch readiness, and post-approval activities.

Responsibilities

• Develop US and global regulatory strategies aligned with business goals.
• Lead regulatory team and coordinate meetings with authorities.
• Ensure compliance with FDA, EU, ICH, EMA standards.
• Manage post-approval labeling updates and variations.
• Collaborate with Commercial, Legal, Quality, and others for launch readiness.

Skills

Regulatory leadership

Regulatory strategy

Cross-functional collaboration

FDA/EMA knowledge

Team management

Education

Advanced degree

Job description

NewAmsterdam Pharma Company is seeking a Senior Vice President, Head of Global Regulatory Affairs to lead regulatory strategy across global submissions for late-stage programs and post-approval lifecycle management. The role is remote in the USA and reports to the Chief Medical Officer.

You will guide development teams, manage interactions with FDA, EMA, and other authorities, and build a high-performing regulatory function while coordinating with Commercial, Legal, and Quality to ensure timely