Regulatory Safety Lead (MD) (Pharmaceuticals)

TL;DR

Regulatory Safety Lead (Pharmaceuticals): Leading pharmacovigilance and regulatory safety operations for biotech and pharmaceutical clients with an accent on FDA interactions and NDA/BLA submissions. Focus on building and scaling PV infrastructure in preparation for commercialization and supporting the 2026 NDA submission.

Location: Must be based in the United States; Remote working supported, hybrid encouraged for those near offices.

Company

hirify.global provides end-to-end consulting solutions in regulatory sciences, clinical research, and pharmacovigilance to biotech and pharmaceutical organizations.

What you will do

• Assume the core responsibilities of the PV Head to drive regulatory safety strategies.
• Represent the organization before the FDA and other global regulatory authorities, owning safety interactions and inspections.
• Oversee global PV operations, including case management, safety surveillance, and risk management.
• Support late-stage development and the critical 2026 NDA submission.
• Build, scale, and govern fit-for-purpose PV processes and infrastructure for commercialization.
• Perform benefit-risk assessments and manage PV quality systems.

Requirements

• MD degree is required.
• Previous experience as Head of Pharmacovigilance or Global Drug Safety (large pharma or established biotech strongly preferred).
• 15+ years of progressive experience in PV and regulatory safety within the biotech or pharma industry.
• Deep hands-on experience with FDA interactions and ownership of safety inspections.
• Demonstrated expertise supporting NDA/BLA submissions.
• Must be based in the USA.

Culture & Benefits

• Commitment to diversity, equity, and inclusion, creating a safe space for authentic expression.
• Entrepreneurial, innovative, and collaborative work environment.
• Support for remote working with optional hybrid collaboration.
• Personal application review by the recruitment team without the use of AI screening tools.