Regulatory Affairs & Pharmacovigilance Manager

TL;DR

Regulatory Affairs & Pharmacovigilance Manager: Ensuring compliance of Expanded Access Program (EAP) processes with country-specific regulations globally with an accent on regulatory strategy, pharmacovigilance alignment, and dossier submissions. Focus on building cross-functional regulatory and quality infrastructure for biologicals, cell therapies, and synthetic drugs while supporting audits, client communications, and SOP/QI/CAPA documentation.

Location: North America candidates must reside in EST or CST time zones

Company

hirify.global is a global health tech company building AI-powered technology to simplify access to drugs in development.

What you will do

• Develop and execute regulatory strategies for Expanded Access Programs (EAPs) for biologicals, cell therapies, and synthetic drugs.
• Serve as the regulatory and pharmacovigilance expert for client communications and submissions to Health Authorities, including cross-functional meetings and audits.
• Prepare, compile, and submit regulatory dossiers for cohort and named patient EAPs on behalf of clients.
• Support EAP setup and execution strategy (where, when, and how) and collaborate with Commercial on new EAPs.
• Ensure timely, compliant handling of regulatory and pharmacovigilance activities related to EAPs.
• Maintain regulatory documentation and templates, and coordinate with a pharmacovigilance service provider; contribute to SOPs, QIs, and CAPAs.

Requirements

• Geography/time zone: For candidates in North America, must reside within the EST or CST time zones.
• ~5 years of experience in Regulatory Affairs, including Expanded Access experience.
• Working knowledge of fundamental pharmacovigilance principles.
• Solid understanding of national and international legislation and regulations related to Expanded Access.
• Bachelor’s or Master’s degree in Life Sciences or a related field.
• Strong written and verbal English communication skills.

Culture & Benefits

• Hybrid working model if based in the Netherlands.
• Competitive salary with annual performance bonus and Employee Stock Option Plan.
• Learning and development budget plus internal knowledge-sharing sessions.
• Support for working parents and access to professional guidance via certified psychologists (OpenUp).
• Monthly Culture Club events and an annual company-wide celebration.

Hiring process

• Interviews with cross-functional stakeholders, including regulatory leadership.
• Assessment of regulatory and pharmacovigilance expertise and experience with Expanded Access.