Vice President, Regulatory Affairs

• Develop and execute global regulatory strategies for the company's oncology portfolio
• Advise executive leadership and the Board of Directors on regulatory risks, opportunities, timelines, and competitive landscape considerations
• Establish regulatory strategies supporting global market expansion and lifecycle management
• Lead interactions with FDA, EMA, MHRA, PMDA, Health Canada, and other global regulatory agencies
• Serve as the principal regulatory representative in key agency meetings
• Direct preparation of briefing documents, regulatory responses, and Health Authority communications
• Lead strategy and execution for INDs, CTAs, NDA/BLA submissions, MAA filings, amendments, annual reports, and post-marketing commitments
• Align Clinical, Nonclinical, CMC, Biostatistics, Quality, and Medical Writing teams for major submissions
• Oversee regulatory documentation for scientific excellence and compliance
• Drive submission readiness for marketing applications and commercial launch
• Collaborate on study design, endpoint selection, statistical considerations, global registration strategies, protocols, and major clinical program decisions
• Provide regulatory guidance for oncology development programs, including rare cancers and orphan indications
• Lead activities supporting product labeling, launch readiness, post-marketing commitments, and lifecycle management
• Ensure ongoing compliance throughout the product lifecycle
• Support business development, licensing evaluations, and due diligence
• Contribute regulatory expertise to corporate strategy, investor communications, and strategic planning

Requirements

• Advanced degree in a scientific discipline required
• PhD, PharmD, MD, or equivalent strongly preferred
• 15+ years of progressive Regulatory Affairs experience or related experience within biotechnology and/or pharmaceutical organizations
• Significant experience leading regulatory strategy for late-stage clinical development
• Oncology and combination product development preferred
• Demonstrated success leading NDA, BLA, MAA, or equivalent global registration submissions and approvals
• Deep knowledge of U.S. and international regulatory frameworks governing drug and device development
• Extensive experience interacting directly with FDA and other major global Health Authorities
• Experience in ocular oncology, solid tumors, rare cancers, precision oncology, immuno-oncology, or targeted therapies preferred
• Prior experience supporting product approvals and commercial launches within an oncology-focused biotechnology company preferred
• Previous experience in a publicly traded biotechnology company preferred
• Ability to translate regulatory requirements into actionable business strategies
• Executive presence and ability to influence stakeholders across all levels of the organization
• Strong judgment and ability to balance regulatory risk with development objectives
• Exceptional communication, negotiation, and relationship-building skills
• Ability to navigate complex and rapidly evolving regulatory landscapes
• Leadership, ownership of outcomes, accountability, transparent communication, and empowerment of others

Core Competencies

Demonstrates extensive expertise in developing and executing global regulatory strategies for oncology products, with a strong focus on leading submissions such as NDA, BLA, and MAA. Possesses advanced knowledge of regulatory frameworks and the ability to influence stakeholders while ensuring compliance throughout the product lifecycle.

Highest-signal resume keywords

• Regulatory Affairs Experience
• Oncology Development Programs
• NDA/BLA/MAA Submissions
• FDA Interaction
• Advanced Degree in Scientific Discipline

ATS Optimization Keywords

Hard Skills

• Regulatory Strategy Development
• Global Market Expansion
• Submission Readiness
• Regulatory Documentation
• Clinical Program Collaboration
• Regulatory Compliance
• Product Labeling
• Lifecycle Management
• INDs/CTAs Management
• Health Authority Communications

Soft Skills

• Exceptional Communication
• Negotiation Skills
• Relationship-Building
• Leadership
• Judgment

Certifications & Qualifications

• PhD
• PharmD
• MD

Industry Keywords

• Oncology
• Biotechnology
• Pharmaceuticals
• Regulatory Frameworks
• Rare Cancers
• Immuno-Oncology
• Targeted Therapies
• Ocular Oncology
• Publicly Traded Biotechnology
• Global Regulatory Agencies