Regulatory Safety Lead (MD)

TL;DR

Regulatory Safety Lead (MD): Overseeing global pharmacovigilance operations and regulatory safety strategy for a critical 2026 NDA submission with an accent on FDA interactions and safety surveillance. Focus on building and scaling PV infrastructure and governing benefit-risk assessment processes for late-stage drug development.

Location: Must be based in the United States. Hybrid work is encouraged for those near company offices.

Company

hirify.global provides expert consulting and operational support across the complete product lifecycle for biotech, med device, and pharmaceutical organizations.

What you will do

• Lead global pharmacovigilance operations and safety surveillance strategies.
• Represent the organization to the FDA and global regulatory authorities during inspections and safety interactions.
• Oversee case management, risk management, and benefit-risk assessment processes.
• Build and govern fit-for-purpose PV infrastructure in preparation for commercialization.
• Directly support late-stage development and upcoming NDA/BLA submissions.

Requirements

• MD degree required.
• 15+ years of progressive experience in pharmacovigilance and regulatory safety within the biotech or pharmaceutical industry.
• Proven track record as a Head of Pharmacovigilance or Global Drug Safety lead.
• Deep hands-on experience with FDA regulatory interactions and safety inspections.
• Demonstrated success in supporting late-stage development and NDA/BLA submissions.
• Must be authorized to work in the United States.

Culture & Benefits

• Commitment to diversity, equity, and inclusion.
• Collaborative and entrepreneurial work environment.
• Support for hybrid collaboration where proximity to offices allows.
• Opportunity to lead high-profile drug safety programs.