Regulatory Affairs Director - Remote

3w3 weeks ago

myTomorrows

CA · Full-time · $200,000 – $260,000

About this role

myTomorrows is a global health tech company dedicated to breaking down barriers for patients seeking treatment options. We bridge the gap between those searching for possible options and the companies who develop them, using a cutting-edge AI-powered technology platform to simplify and streamline access to drugs in development.

As Regulatory Affairs Director, you will translate global regulatory strategy into execution across programs, regions, and service lines. You will oversee a portfolio of regulatory activities including Expanded Access Programs, Clinical Trials, and Real-World Data initiatives, ensuring high-quality, compliant, and timely delivery.

You will lead, coach, and develop a team of Regulatory Affairs professionals, setting clear expectations and driving accountability for performance. Working closely with Program Management, Medical Affairs, Quality Assurance, and Supply Chain, you will ensure regulatory input is embedded into end-to-end program delivery.

This role sits at the intersection of strategy, delivery, and leadership, and is key to scaling our Regulatory Affairs capabilities globally. With a global footprint spanning 134 countries and a recent €25M investment, you will shape the future of treatment access - making tomorrow's therapies accessible for people who need them today.

Requirements

Demonstrated experience in regulatory affairs within the pharmaceutical or biotech industry
Proven ability to translate global regulatory strategy into execution across programs and regions
Experience overseeing Expanded Access Programs (EAPs), Clinical Trials, and/or Real-World Data initiatives
Strong leadership skills with experience coaching and developing regulatory professionals
Ability to manage multiple regulatory programs simultaneously, balancing timelines, quality, and client expectations
Deep understanding of regulatory compliance, quality standards, and risk management
Must reside within the EST or CST time zones for seamless collaboration with teams

Responsibilities

Translate company and RA/PV strategy into clear regulatory plans across programs and regions
Drive implementation across Expanded Access Programs (EAPs), Clinical Trials, and Real-World Data initiatives
Oversee multiple regulatory programs simultaneously, ensuring delivery against timelines, quality standards, and client expectations
Identify and proactively manage cross-program risks, dependencies, and resource constraints
Lead, coach, and develop Regulatory Affairs Managers and senior team members
Partner closely with Program Management, Medical Affairs, Quality Assurance, and Supply Chain
Drive standardization, consistency, and scalability of regulatory processes
Act as a senior point of contact for clients on regulatory matters and support client discussions, audits, and regulatory interactions with Health Authorities

Benefits

Remote work within EST or CST time zones
Opportunity to shape the future of treatment access at a mission-driven global health tech company
Work with a cutting-edge AI-powered technology platform that simplifies drug access
Join a company with a global footprint spanning 134 countries and recent €25M investment to scale