Regulatory Affairs / Pharmacovigilance Manager

4w1 month ago

myTomorrows

CA · Full-time · $130,000 – $160,000

About this role

myTomorrows is a global health tech company dedicated to breaking down barriers for patients seeking treatment options. As the Regulatory Affairs and Pharmacovigilance Manager, you will ensure compliance of our processes with country-specific expanded access regulations globally.

You will support the development and execution of regulatory strategies for Expanded Access Programs (EAPs) involving biologicals, cell therapies, and synthetic drugs. You will prepare, compile, and submit regulatory dossiers for cohort and named patient EAPs on behalf of clients.

Working closely with Medical Affairs, Program Management, Quality Assurance, and Supply Chain, you will act as the Regulatory Affairs and Pharmacovigilance expert for client communications and Health Authority submissions. You will liaise with the Pharmacovigilance service provider to ensure alignment and compliance.

This role offers the opportunity to shape the future of treatment access by contributing to a cutting-edge AI-powered platform. You will help connect key stakeholders in the drug development ecosystem, supporting over 17,000 patients globally.

Requirements

Approximately 5 years of relevant experience in Regulatory Affairs, including experience in Expanded Access.
Working knowledge of fundamental principles of Pharmacovigilance.
Experience preparing and submitting regulatory dossiers to Health Authorities.
Knowledge of global expanded access regulations and guidelines.
Strong understanding of SOPs, QIs, and CAPAs in a regulated environment.
Ability to collaborate cross-functionally with Medical Affairs, Quality, and Supply Chain.

Responsibilities

Support the development and execution of regulatory strategies for Expanded Access Programs (EAPs) involving biologicals, cell therapies, and synthetic drugs.
Act as the Regulatory Affairs and Pharmacovigilance expert for communications with clients and submissions to Health Authorities, as well as cross-functional meetings and audits.
Prepare, compile, and submit regulatory dossiers for cohort and named patient Expanded Access Programs (EAPs) on behalf of clients.
Provide input and support for the regulatory strategy for setting up and executing EAPs (e.g., where, when, and how).
Collaborate with the Commercial team to support new EAPs.
Ensure timely and compliant handling of all regulatory and pharmacovigilance activities related to EAPs.
Liaise with the Pharmacovigilance service provider to ensure alignment and compliance.
Contribute to maintaining department documentation such as SOPs, QIs, and CAPAs.

Benefits

Work remotely within EST or CST time zones.
Be part of a mission-driven company shaping the future of treatment access.
Gain exposure to a global network of stakeholders including BioPharma, HCPs, and regulatory authorities.