Global Regulatory Strategy Director (Remote)

NewAmsterdam Pharma B.V.; United States; Remote; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health insurance

Dental coverage

Vision coverage

Life & disability insurance

Retirement plans

Job summary

NewAmsterdam Pharma is seeking a Director of Global Regulatory Affairs to provide strategic regulatory leadership across assigned programs from a remote US location. You will oversee submissions (INDs, CTAs, MAAs, NDAs), interact with global health authorities, and guide trial design and labeling decisions, balancing detail with the big-picture regulatory strategy.

The role requires 10+ years in regulatory affairs, deep FDA/ICH knowledge, and a proven ability to manage external vendors and

Qualifications

• 10+ years of regulatory affairs experience in pharma, with a clinical-stage focus.
• Proven track record leading regulatory submissions (INDs, CTAs, MAAs, NDAs).
• Deep knowledge of FDA, ICH, and global regulatory pathways.
• Ability to work cross-functional in a fast-paced environment.
• Excellent communication, leadership, and strategic problem-solving skills.

Responsibilities

• Develop and implement regulatory strategies for clinical development programs.
• Lead preparation, submission, and maintenance of regulatory filings (INDs, NDAs, CTAs, MAAs).
• Manage regulatory interactions with global health authorities.
• Provide strategic regulatory guidance on trial design and labelling requirements.
• Stay up to date with evolving regulatory requirements and ensure compliance with FDA/EMA/ICH guidelines.
• Oversee compilation and review of regulatory documents for integrity and compliance.
• Collaborate with clinical, CMC, and quality teams to address regulatory challenges.
• Oversee vendor relationships (consultants/CROs) involved in trials and submissions.
• Monitor vendor performance to meet milestones and budgets.

Skills

Regulatory leadership

Cross-functional collaboration

Regulatory strategy

Communication

Problem solving

Education

PhD/PharmD/MS in life sciences or regulatory affairs

Job description

NewAmsterdam Pharma is seeking a Director of Global Regulatory Affairs to provide strategic regulatory leadership across assigned programs from a remote US location. You will oversee submissions (INDs, CTAs, MAAs, NDAs), interact with global health authorities, and guide trial design and labeling decisions, balancing detail with the big-picture regulatory strategy.

The role requires 10+ years in regulatory affairs, deep FDA/ICH knowledge, and a proven ability to manage external vendors and