Senior Vice President, Global Regulatory Affairs

NewAmsterdam Pharma Corporation

. Develop US and global regulatory strategies aligned with business objectives .

Posted 9/21/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive regulatory expertise with a focus on US and EU laws, drug development processes, and post-approval activities. Proven leadership in guiding cross-functional teams and developing regulatory strategies for late-stage and commercial-stage products.

Highest-signal resume keywords

Regulatory Strategy DevelopmentLeadership in Regulatory AffairsDrug Development Process KnowledgePost-Approval Regulatory ActivitiesCross-Functional Team Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory StrategyRegulatory ComplianceDrug DevelopmentRegulatory SubmissionsLabeling StrategyRisk AssessmentProject ManagementRegulatory PoliciesClinical Development PlansInformed Consent Authoring

Soft Skills

LeadershipCommunicationInterpersonal SkillsTeam CollaborationProblem-Solving

Certifications & Qualifications

Advanced Degree Preferred

Industry Keywords

FDAEU RegulationsICH GuidelinesEMAPharmacovigilanceMarket AccessGood Distribution PracticesLifecycle ManagementRegulatory AuthoritiesCommercial Strategy

About the role

Key responsibilities & impact

Develop US and global regulatory strategies aligned with business objectives
Provide guidance, direction, and leadership on regulatory strategies to the development team and senior management
Make strategic contributions to clinical development plans
Lead the regulatory team in providing expert advice to development teams and operationalizing key regulatory activities
Identify talent growth opportunities and forecast team capability needs as the pipeline evolves
Prepare meeting requests and briefing documents, coordinate and prepare teams for meetings, and serve as the primary liaison with regulatory authorities
Maintain working knowledge of US and EU laws, regulations, guidelines, and the global regulatory environment
Identify and collaborate with regulatory experts and consultants
Coordinate and prepare responses to requests for information from regulatory authorities
Represent Regulatory Affairs on cross-functional development teams
Establish, update, and implement regulatory policies, standards, and procedures
Lead global regulatory strategy across late-stage development, launch readiness, product registration, and post-approval lifecycle management
Partner with Commercial, Medical Affairs, Legal/Compliance, Quality, Pharmacovigilance, Supply Chain, and Market Access on launch readiness, compliant communications, labeling, and lifecycle planning
Ensure regulatory operations comply with FDA, EU, ICH, EMA, and industry standards
Manage regulatory aspects of products and projects, including timelines and deliverables
Guide electronic regulatory submissions and support development teams in their preparation
Author, review, and edit informed consents, Investigator’s Brochures, study materials, essential documents, presentations, and reports
Work with the selected EU Designated Person to ensure Good Distribution Practices of API
Report to the Chief Medical Officer

Requirements

What you’ll need

Advanced degree preferred
15+ years of regulatory experience
Minimum of 10 years of experience in a senior leadership role
Demonstrated leadership competencies in establishing clear direction and objectives; ability to simplify complex processes and foster an environment that brings out the best in people
Experience leading a team of regulatory professionals and external partners, with a preference for leading a team through stages of company expansion
Excellent working knowledge of drug development process and understanding of regulatory environment across USA, EU, and other regions
Demonstrated experience leading regulatory strategy for late-stage, launch, and commercial-stage products in the US and ex-US markets
Experience with post-approval regulatory activities, including labeling strategy, safety-related updates, CMC changes, post-approval commitments, renewals, and supplements/variations
Proven ability to advise executive and commercial leadership on regulatory risks affecting launch timing, market access, labeling, competitive positioning, promotional strategy, and lifecycle management
Ability to provide strong regulatory leadership on a cross-functional team
Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development
Excellent listening, communication, and interpersonal skills, with a track record of fostering team collaboration and consistently delivering high-quality work
Ability to accurately project timelines and manage them across regulatory projects

Benefits

Comp & perks

Annual bonus
Long-term incentives
Health insurance
Dental and vision coverage
Term life and disability coverage
Retirement plans
Remote position
Travel required as determined to meet business requirements