Global Regulatory Affairs Director (Remote Biotech)

Regulatory Jobs; United States; Remote; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health insurance

Dental and vision coverage

Term life and disability coverage

Retirement plans

Job summary

NewAmsterdam Pharma seeks a Director, Global Regulatory Affairs to provide regulatory leadership across programs, focusing on strategy, filings, compliance, and lifecycle management. You will work with cross-functional teams and manage external vendors to ensure timely regulatory filings and high-quality submissions.

The role requires extensive FDA/EMA knowledge, strong leadership, and the ability to balance detail with a strategic view of development programs.

Qualifications

• Advanced degree in life sciences, regulatory affairs, or related field.
• 10+ years regulatory affairs experience in pharma/biotech, clinical-stage.
• Proven track record of leading regulatory submissions (INDs, CTAs, MAAs, NDAs).
• Deep knowledge of FDA, ICH guidelines, and global regulatory pathways.
• Ability to work cross-functional in a fast-paced environment.
• Excellent communication, leadership and strategic problem-solving skills.
• Remote role with in-person attendance at the Philadelphia area office when needed.

Responsibilities

• Develop regulatory strategies for clinical development programs aligned with business objectives.
• Lead preparation, submission, and maintenance of regulatory filings (INDs, NDAs, CTAs, MAAs) and manage global health authority interactions.
• Provide strategic regulatory guidance on trial design and labeling requirements.
• Stay current with evolving regulatory requirements; ensure FDA/EMA/ICH compliance.
• Oversee compilation and review of regulatory documents with scientific integrity.
• Collaborate with clinical, CMC, and quality teams to address regulatory challenges and accelerate timelines.
• Oversee relationships with external vendors (consultants, CROs) for trials and submissions; ensure quality and timelines.
• Monitor vendor performance and address delays to meet milestones on time and budget.

Skills

Regulatory strategy

Regulatory submissions

FDA/EMA knowledge

Cross-functional collaboration

Strategic problem-solving

Education

Advanced degree (Ph.D./Pharm.D./MS)

Job description

NewAmsterdam Pharma seeks a Director, Global Regulatory Affairs to provide regulatory leadership across programs, focusing on strategy, filings, compliance, and lifecycle management. You will work with cross-functional teams and manage external vendors to ensure timely regulatory filings and high-quality submissions.

The role requires extensive FDA/EMA knowledge, strong leadership, and the ability to balance detail with a strategic view of development programs.