Global Regulatory Strategy Lead — Remote

NewAmsterdam Pharma Company N.V.; United States; A distancia; USD 140.000 - 190.000; Jornada completa

Descripción de la vacante

NewAmsterdam Pharma is seeking a Senior Manager, Global Regulatory Affairs to lead regulatory strategy for our investigational therapies. This remote USA role requires collaboration with cross-functional teams and external vendors to drive filings and lifecycle management.

You will guide submissions (INDs/NDAs/CTAs/MAAs), ensure FDA/EMA/ICH compliance, and mentor staff, with a focus on timely, compliant approvals and strong vendor oversight.

Formación

• Advanced degree in life sciences, regulatory affairs, or related field.
• 7+ years of regulatory affairs experience in the pharmaceutical industry.
• Experience supporting regulatory submissions (INDs, CTAs, MAAs, NDAs) and knowledge of FDA/ICH.

Responsabilidades

• Develop and implement regulatory strategies aligned with program goals.
• Prepare, submit, and maintain regulatory filings (INDs, NDAs, CTAs, MAAs).
• Provide regulatory guidance on trial design and labeling requirements.
• Stay up to date with FDA, EMA, and ICH guidelines and ensure compliance.
• Collaborate with clinical, CMC, and QA teams to address challenges.
• Manage relationships with external vendors (consultants, CROs) and monitor performance.

Conocimientos

Regulatory strategy

Vendor management

Cross-functional teamwork

Regulatory affairs expertise

Regulatory submissions

Educación

Advanced degree (Ph.D./Pharm.D./M.S.)

Descripción del empleo

NewAmsterdam Pharma is seeking a Senior Manager, Global Regulatory Affairs to lead regulatory strategy for our investigational therapies. This remote USA role requires collaboration with cross-functional teams and external vendors to drive filings and lifecycle management.

You will guide submissions (INDs/NDAs/CTAs/MAAs), ensure FDA/EMA/ICH compliance, and mentor staff, with a focus on timely, compliant approvals and strong vendor oversight.