Global Regulatory Affairs Senior Manager — Remote

NewAmsterdam Pharma Corporation; United States; Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Dental coverage

Vision coverage

Retirement plans

Job summary

NewAmsterdam Pharma is seeking a Senior Manager, Global Regulatory Affairs to lead regulatory strategies for clinical programs, focusing on submissions and lifecycle management. This remote (USA) role collaborates with cross-functional teams and external vendors to ensure timely filings and compliant documentation.

The ideal candidate has 7+ years in regulatory affairs, advanced life sciences degree, and deep knowledge of FDA, EMA, ICH guidelines.

Qualifications

• 7+ years in regulatory affairs within pharma, focusing on clinical-stage development.
• Experience preparing INDs, NDAs, CTAs, MAAs, and NDA filings.
• Strong knowledge of FDA, ICH guidelines, and global regulatory pathways.

Responsibilities

• Support development and execution of regulatory strategies for clinical programs.
• Prepare, submit, and maintain regulatory filings with global authorities.
• Provide regulatory guidance on trial design and labeling.
• Monitor evolving requirements to ensure FDA/EMA/ICH compliance.
• Collaborate with CROs and vendors to meet timelines and quality.
• Manage vendor relationships and monitor performance.
• Ensure vendor deliverables meet regulatory standards and budgets.

Skills

Regulatory strategy

Vendor management

Cross-functional collaboration

Regulatory submissions

FDA/EMA knowledge

Education

Advanced degree in life sciences

Job description

NewAmsterdam Pharma is seeking a Senior Manager, Global Regulatory Affairs to lead regulatory strategies for clinical programs, focusing on submissions and lifecycle management. This remote (USA) role collaborates with cross-functional teams and external vendors to ensure timely filings and compliant documentation.

The ideal candidate has 7+ years in regulatory affairs, advanced life sciences degree, and deep knowledge of FDA, EMA, ICH guidelines.