Vice President, Nonclinical Emerging Therapies (Regulatory Sciences)

TL;DR

Vice President, Nonclinical Emerging Therapies (Regulatory Sciences): Leading regulatory strategy and nonclinical development activities for therapeutic drugs, biologics, and medical devices with an accent on FDA interactions and emerging therapeutic modalities. Focus on translating complex regulatory requirements into effective development plans and managing cross-functional teams to accelerate client product approvals.

Location: Must be based in the United States. Hybrid work is encouraged for those within commuting distance of an office.

Company

hirify.global provides end-to-end consulting solutions for the biotech, med device, and pharmaceutical industries, focusing on regulatory sciences, clinical research, and quality compliance.

What you will do

• Serve as the primary point of contact for clients regarding nonclinical regulatory matters.
• Lead nonclinical discussions and interactions with the FDA, including briefing packages and submissions.
• Coordinate priorities across corporate, scientific, and clinical stakeholders within Product Development Teams.
• Develop and implement regulatory strategies to ensure cost-effective and compliant product approvals.
• Support new business development efforts to expand the client portfolio.
• Provide critical review of documentation supporting regulatory applications.

Requirements

• 10+ years of leadership experience in Regulatory Sciences within consulting or regulated drug/biologic development.
• Master’s degree in Life Sciences (PhD preferred).
• Proven ability to engage with regulatory agencies and manage complex, multi-stakeholder projects.
• Strong understanding of regulatory pathways for drugs, biologics, and medical device combination products.
• Experience leading teams of technical professionals.
• Excellent oral and written communication skills.

Culture & Benefits

• Commitment to diversity, equity, and inclusion.
• Supportive environment for innovative and entrepreneurial spirits.
• Personalized application review process without AI screening tools.
• Flexible work arrangements with support for remote and hybrid collaboration.