Remote Director, Global Regulatory Strategy

NewAmsterdam Pharma Company; Northern (KY); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health insurance

Annual bonus

Long-term incentives

Job summary

NewAmsterdam Pharma is seeking a Director of Global Regulatory Affairs for a remote role in the USA. You will lead regulatory strategy, submissions, and lifecycle management across clinical programs, coordinating with internal teams and external vendors to ensure timely filings with FDA/EMA and other authorities.

The role requires an advanced degree and 10+ years in regulatory affairs, with strong leadership, communication, and strategic problem-solving skills.

Qualifications

• Advanced degree in life sciences or regulatory affairs.
• Experience leading regulatory submissions (INDs/NDAs/CTAs/MAAs) and lifecycle management.
• Strong knowledge of FDA, EMA, ICH guidelines and global pathways.

Responsibilities

• Develop and implement regulatory strategies for clinical programs.
• Lead regulatory filings and interactions with global health authorities.
• Provide strategic regulatory guidance to clinical trial design and labeling.
• Manage external vendors and ensure timely, compliant deliverables.
• Monitor evolving regulations and maintain compliant practices.

Skills

Regulatory strategy

IND/NDAs/CTAs

Global health authority interactions

Cross-functional leadership

Education

Ph.D./Pharm.D./MS in life sciences or regulatory affairs

Job description

NewAmsterdam Pharma is seeking a Director of Global Regulatory Affairs for a remote role in the USA. You will lead regulatory strategy, submissions, and lifecycle management across clinical programs, coordinating with internal teams and external vendors to ensure timely filings with FDA/EMA and other authorities.

The role requires an advanced degree and 10+ years in regulatory affairs, with strong leadership, communication, and strategic problem-solving skills.