Global Regulatory Strategy Lead - Remote

Regulatory Jobs; United States; Remote; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Dental coverage

Vision coverage

Retirement plans

Annual bonus

Long-term incentives

Job summary

NewAmsterdam Pharma is seeking a Senior Manager, Global Regulatory Affairs to lead regulatory strategies for investigational therapies and manage submissions worldwide. The role emphasizes vendor oversight, cross-functional collaboration, and maintaining compliance with FDA, EMA, and ICH guidelines.

You will work with internal teams and external vendors to drive timely regulatory milestones. The ideal candidate has an advanced life sciences degree and 7+ years in regulatory affairs, with strong

Qualifications

• Advanced degree in life sciences or regulatory affairs (PhD/PharmD/MS).
• 7+ years in regulatory affairs or related pharma roles.
• Experience supporting INDs/NDAs/MAAs and global submissions.

Responsibilities

• Develop regulatory strategies for clinical development programs.
• Prepare and maintain regulatory filings (INDs, NDAs, CTAs, MAAs).
• Guide internal stakeholders on trial design and labeling.
• Coordinate with FDA/EMA/ICH guidelines and maintain compliance.
• Manage external vendors for submissions and timelines.
• Collaborate with clinical, CMC, and QA teams on regulatory issues.
• Monitor vendor performance and ensure milestones are met.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory communications

Problem solving

Education

Advanced degree in life sciences/regulatory affairs (PhD/PharmD/MS)

Job description

NewAmsterdam Pharma is seeking a Senior Manager, Global Regulatory Affairs to lead regulatory strategies for investigational therapies and manage submissions worldwide. The role emphasizes vendor oversight, cross-functional collaboration, and maintaining compliance with FDA, EMA, and ICH guidelines.

You will work with internal teams and external vendors to drive timely regulatory milestones. The ideal candidate has an advanced life sciences degree and 7+ years in regulatory affairs, with strong