Remote Director, Global Regulatory Affairs

NewAmsterdam Pharma Corporation; United States; Remote; USD 180,000 - 260,000; Full time

Benefits offered by this job

Health insurance

Dental and vision coverage

Term life and disability coverage

Retirement plans

Job summary

NewAmsterdam Pharma is seeking a Director of Global Regulatory Affairs to lead regulatory strategy, submissions, and lifecycle management for clinical programs. The role requires cross-functional collaboration with internal teams and external vendors to ensure timely regulatory filings and alignment with global guidelines.

The ideal candidate has 10+ years of regulatory affairs experience, a proven submissions track record, and deep knowledge of FDA/ICH pathways.

Qualifications

• 10+ years of regulatory affairs experience in pharmaceutical industry.
• Proven track record of leading regulatory submissions (INDs, CTAs, MAAs, NDAs).
• Deep knowledge of FDA regulations, ICH guidelines, and global regulatory pathways.

Responsibilities

• Develop and implement regulatory strategies for clinical programs, aligned with business objectives.
• Lead preparation, submission, and maintenance of regulatory filings (INDs, NDAs, CTAs, MAAs) and manage interactions with health authorities.
• Provide strategic regulatory guidance to internal stakeholders on trial design and labeling requirements.
• Stay updated with evolving regulations and ensure compliance with FDA, EMA, ICH guidelines.
• Collaborate with clinical, CMC, and quality teams to address regulatory challenges and expedite timelines.
• Oversee management of external vendors (consultants, CROs) and ensure deliverables meet requirements.

Skills

Regulatory strategy

Cross-functional leadership

Vendor management

FDA/ICH knowledge

Education

Ph.D., Pharm.D., or M.S. in life sciences

Job description

NewAmsterdam Pharma is seeking a Director of Global Regulatory Affairs to lead regulatory strategy, submissions, and lifecycle management for clinical programs. The role requires cross-functional collaboration with internal teams and external vendors to ensure timely regulatory filings and alignment with global guidelines.

The ideal candidate has 10+ years of regulatory affairs experience, a proven submissions track record, and deep knowledge of FDA/ICH pathways.