Global Regulatory Strategy Director

A leading biopharmaceutical company located in California is seeking a Senior Director of Regulatory Affairs. This role is pivotal in developing global regulatory strategies for oncology products, ensuring compliance with major government authorities, and leading the regulatory team. Candidates should possess a strong background in pharmaceutical regulatory...

Senior Director, Regulatory Affairs - Global Regulatory Leader About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique...

About Us: Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with...

Location: Palo Alto, CA / Miami, FL / Princeton, NJ onsite About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique...

Location: Palo Alto, CA / Miami, FL / Princeton, NJ onsite About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique...

An international life sciences company is seeking a Senior Director to lead their global regulatory strategy and operations. The ideal candidate will have extensive experience in regulatory affairs, particularly with FDA and international bodies. This role involves mentoring junior team members and preparing regulatory documents. Compensation ranges from...

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 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...

An innovative firm seeks a Senior Director of Fintech Legislative and Regulatory Affairs to shape the future of fintech in the Middle East. This role involves crafting regulatory strategies, managing complex projects, and leading market expansion for global clients. The ideal candidate will have extensive experience in regulatory affairs, exceptional...

A leading biotech firm in San Francisco is seeking a Senior Director to lead global regulatory strategy and operations. The ideal candidate will have an advanced degree and over 10 years of experience in regulatory affairs. Key responsibilities include overseeing regulatory submissions and leading interactions with FDA and international authorities. This...