Hybrid Global Regulatory Strategy Director – Oncology

A leading global biopharmaceutical company is seeking a Senior Director, Global Regulatory Lead – Oncology in Boston, MA. This role involves leading global regulatory strategy for complex oncology programs, setting regulatory direction, and ensuring compliance with FDA submissions. The ideal candidate should possess significant experience in regulatory...

OverviewOlema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor...

OverviewSenior Director, Global Regulatory Strategy Lead - Regulatory Affairs at Olema Oncology. Reports to the Senior Vice President of Regulatory Affairs. Location: Boston, MA or San Francisco, CA. Domestic and international travel up to 20%.ResponsibilitiesLead the development of the New Drug Application (NDA)Lead the development and execution of...

A leading global biopharmaceutical company is seeking a Director, Global Regulatory Lead Oncology to set global regulatory strategy and handle submissions for high-impact oncology programs. The ideal candidate will have at least 8 years of experience in regulatory affairs, solid knowledge of the drug development process, and exceptional communication and...

A biotechnology company focused on oncology is seeking a Senior Manager for Global Regulatory Affairs Strategy in Boston. The ideal candidate will support regulatory strategy, lead clinical trial submissions, and represent Regulatory Affairs on cross-functional teams. A strong background with at least 5 years in regulatory affairs in the pharmaceutical...

Overview Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral...

A leading pharmaceutical company is hiring an Associate Director, Global Regulatory Lead Oncology in Boston, MA. In this role, you will define and lead global regulatory strategies for oncology programs while overseeing major submissions to the FDA. The ideal candidate will have at least 6 years of relevant experience, a strong scientific background, and...

Senior Manager, Global Regulatory Affairs Strategy Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in...

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Director, Global Regulatory Lead OncologyAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients...