Remote SVP, Global Regulatory Affairs Leader

NewAmsterdam Pharma Corporation; United States; Remote; USD 350,000 - 550,000; Full time

Benefits offered by this job

Competitive base salary

Annual bonus

Long-term incentives

Health insurance

Dental and vision coverage

Term life and disability coverage

Retirement plans

Job summary

NewAmsterdam Pharma Corporation is seeking a SVP, Head of Global Regulatory Affairs to shape regulatory strategy and oversee global submissions for commercial products across regions. The role leads strategic direction and operations for Regulatory Affairs and is responsible for all regulatory aspects related to CMC, preclinical, clinical development, and post‑approval activities worldwide.

Reporting to the Chief Medical Officer, you will build and lead a high‑performing regulatory team,

Qualifications

• Experience leading regulatory professionals and external partners.
• Strong knowledge of drug development and regulatory environments in USA and EU.
• Excellent leadership and communication skills.

Responsibilities

• Develop US and global regulatory strategies aligned with business objectives.
• Lead regulatory team to provide expert advice to development teams.
• Interface with regulatory authorities as the primary liaison for day-to-day interactions.
• Coordinate responses to information requests from regulators and maintain up-to-date regulatory knowledge.
• Partner with Commercial, Medical Affairs, Legal/Compliance, Quality, Pharmacovigilance, and Market Access for launch readiness.

Skills

Regulatory leadership

Regulatory strategy

Global submissions

Cross-functional collaboration

FDA/EMA knowledge

Education

Advanced degree preferred

Job description

NewAmsterdam Pharma Corporation is seeking a SVP, Head of Global Regulatory Affairs to shape regulatory strategy and oversee global submissions for commercial products across regions. The role leads strategic direction and operations for Regulatory Affairs and is responsible for all regulatory aspects related to CMC, preclinical, clinical development, and post‑approval activities worldwide.

Reporting to the Chief Medical Officer, you will build and lead a high‑performing regulatory team,