Remote Global Regulatory Strategy Director

NewAmsterdam Pharma Company N.V.; United States; On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Health insurance

Dental and vision coverage

Life and disability coverage

Retirement plans

Job summary

NewAmsterdam Pharma is seeking a Director of Global Regulatory Affairs to lead regulatory strategy and submissions across assigned programs. This role collaborates with cross-functional teams and external contractors to ensure timely and compliant filings, while maintaining strategic oversight of lifecycle management.

The ideal candidate has 10+ years in regulatory affairs, advanced life sciences training, and a proven track record of INDs/NDAs/CTAs.

Qualifications

• Advanced degree in life sciences or regulatory affairs.
• 10+ years in regulatory affairs with clinical-stage focus.
• Proven track record of regulatory submissions (INDs/NDAs/CTAs/MAAs).
• Deep knowledge of FDA, ICH guidelines and global pathways.
• Experience leading cross-functional teams and managing external resources.

Responsibilities

• Develop and implement regulatory strategies for clinical development programs.
• Lead preparation, submission, and maintenance of regulatory filings and interactions with health authorities.
• Advise on trial design, labeling requirements, and regulatory compliance.
• Monitor evolving regulatory requirements and ensure adherence to FDA/EMA/ICH guidelines.
• Oversee compilation and review of regulatory documents for scientific integrity and compliance.
• Coordinate with clinical, CMC, and quality teams to address regulatory challenges.
• Manage relationships with external vendors (consultants and CROs) and monitor timelines.

Skills

Cross-functional collaboration

Strategic thinking

Regulatory strategy

Leadership

Education

PhD/PharmD/MS in life sciences or regulatory affairs

Job description

NewAmsterdam Pharma is seeking a Director of Global Regulatory Affairs to lead regulatory strategy and submissions across assigned programs. This role collaborates with cross-functional teams and external contractors to ensure timely and compliant filings, while maintaining strategic oversight of lifecycle management.

The ideal candidate has 10+ years in regulatory affairs, advanced life sciences training, and a proven track record of INDs/NDAs/CTAs.