Global Regulatory Strategy Director NDA Lead

Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs 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...

Senior Director, Global Regulatory Strategy Lead - Regulatory AffairsOlema 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...

Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs 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...

Overview 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 ER+/HER2- metastatic breast cancer. Our follow-on...

A biopharmaceutical company is looking for a Senior Director, Global Regulatory Strategy Lead. This role involves leading the development of regulatory submissions and innovative strategies for oncology products. Ideal candidates have significant experience in regulatory affairs and team leadership. A comprehensive compensation package is offered, along with...

A leading clinical-stage biopharmaceutical company is seeking an experienced regulatory leader in San Francisco to drive global strategy and manage major submissions in oncology. This high-impact role requires 12+ years of experience in Regulatory Affairs, a strong track record with NDA/MAA submissions, and strategic leadership abilities. Join a...

A leading global pharmaceutical company is seeking a Vice President of Regulatory Affairs in Oncology. This role requires extensive experience in Oncology and recent NDA submission experience. You will lead regulatory strategies, oversee compliance, and manage global interactions. This position offers a competitive salary range of $280,560 to $350,700 and...

POSITION SUMMARYGlobal Regulatory Lead, Senior Director role at Dompé is to play a critical role in developing and executing global regulatory strategies to support product development, registration, and compliance. Reporting to the Vice President of Regulatory Affairs, this position will serve as a key liaison with regulatory health authorities, oversee...

Director/Senior Director of Global Regulatory Affairs Director/Senior Director of Global Regulatory Affairs – Rakuten Medical Company Profile Rakuten Medical, Inc. is a global biotechnology company developing precision, cell‑targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads...

General Description : The Director, Global Regulatory Lead, will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders. This individual will manage regulatory...