Remote Director, Global Regulatory Strategy

Regulatory Jobs; Philadelphia (Philadelphia County); Hybrid; USD 180,000 - 280,000; Full time

Benefits offered by this job

Health insurance

Dental and vision coverage

Retirement plans

Annual bonus

Long-term incentives

Job summary

NewAmsterdam Pharma seeks a Director, Global Regulatory Affairs to provide regulatory leadership across clinical programs, shaping strategy, submissions, and lifecycle management. The role involves collaboration with internal teams and external vendors to ensure timely regulatory filings.

The successful candidate will oversee INDs, NDAs, CTAs, and MAAs, maintain alignment with FDA, EMA, and ICH guidelines, and balance strategic priorities with operational execution.

Qualifications

• Advanced degree in life sciences or regulatory affairs.
• 10+ years in regulatory affairs with a focus on clinical-stage development.
• Proven track record leading regulatory submissions (INDs, CTAs, MAAs, NDAs).
• Strong knowledge of FDA regulations, ICH guidelines, and global pathways.
• Ability to work cross-functionally in a fast-paced environment.
• Excellent communication and leadership skills.
• In-person attendance at the Philadelphia area office when required.

Responsibilities

• Develop regulatory strategies for clinical development programs.
• Lead preparation, submission, and maintenance of regulatory filings (INDs, NDAs, CTAs, MAAs).
• Provide strategic regulatory guidance on trial design and labeling requirements.
• Ensure compliance with FDA, EMA, and ICH guidelines across activities.
• Oversee compilation and review of regulatory documents with scientific integrity.
• Collaborate with clinical, CMC, and quality teams to address regulatory challenges.
• Manage relationships with external vendors (consultants and CROs).
• Monitor vendor performance and ensure milestones are met on time and within budget.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional leadership

FDA regulations

ICH guidelines

Vendor management

Education

Ph.D. in life sciences

Pharm.D.

M.S. in regulatory affairs

Job description

NewAmsterdam Pharma seeks a Director, Global Regulatory Affairs to provide regulatory leadership across clinical programs, shaping strategy, submissions, and lifecycle management. The role involves collaboration with internal teams and external vendors to ensure timely regulatory filings.

The successful candidate will oversee INDs, NDAs, CTAs, and MAAs, maintain alignment with FDA, EMA, and ICH guidelines, and balance strategic priorities with operational execution.