Regulatory Affairs & Pharmacovigilance Manager (Healthtech)

TL;DR

Regulatory Affairs & Pharmacovigilance Manager (Healthtech): Ensuring global compliance of expanded access processes with an accent on country-specific regulations and quality infrastructure. Focus on developing regulatory strategies for EAPs, managing submissions to Health Authorities, and maintaining pharmacovigilance alignment.

Location: Remote (US, Canada, UK). For candidates in North America, must reside within the EST or CST time zones

Company

A global health tech company utilizing an AI-powered platform to streamline patient access to drugs in development.

What you will do

• Develop and execute regulatory strategies for Expanded Access Programs (EAPs) involving biologicals, cell therapies, and synthetic drugs.
• Act as the regulatory and pharmacovigilance expert for communications with pharmaceutical clients and submissions to Health Authorities.
• Prepare, compile, and submit regulatory dossiers for cohort and named patient EAPs.
• Collaborate with Commercial, Medical, Program Management, and Quality Assurance teams to support new EAPs.
• Ensure timely and compliant handling of all regulatory and pharmacovigilance activities.
• Maintain department documentation including SOPs, Quality Incidents (QIs), and CAPAs.

Requirements

• Approximately 5 years of experience in Regulatory Affairs, including specific experience in Expanded Access.
• Working knowledge of fundamental Pharmacovigilance principles.
• Solid understanding of national and international legislation relating to Expanded Access.
• Bachelor’s or Master's degree in Life Sciences or a related field.
• Must be based in the US, Canada, or UK.
• North American candidates must reside in EST or CST time zones.

Culture & Benefits

• Competitive salary, annual performance bonus, and Employee Stock Option Plan (ESOP).
• International work environment with a flat organizational structure and scale-up energy.
• Learning and development budget and internal knowledge sharing sessions.
• Unlimited access to professional guidance by certified psychologists via OpenUp.
• Policies to support working parents.
• Company-wide celebrations and monthly events hosted by the Culture Club.