CMC Regulatory Affairs Lead – Biologics

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 cooperative binding to each of its intended targets with multifold higher...

Career Opportunities with Summit Therapeutics Sub, Inc.A great place to work.Careers At Summit Therapeutics Sub, Inc.Current job opportunities are posted here as they become available.Ivonescimab, known as SMT112, is a novel, potential first-in-class investigationalbispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the...

Career Opportunities with Summit Therapeutics Sub, Inc. A great place to work. Careers At Summit Therapeutics Sub, Inc. Current job opportunities are posted here as they become available. 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...

About SummitSummit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this...

About Summit:Ivonescimab, known as SMT112, is a novel, potential first-in-class investigationalbispecific 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 cooperative binding to each of its intended targets with multifold...

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 cooperative binding to each of its intended targets with...

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...

Regulatory Affairs Manager PositionStrategize, plan, and author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities. Support the U.S. Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations,...

Role Overview The Vice President of Regulatory Strategy is responsible for providing regulatory leadership and for the planning and oversight of all regulatory submissions from pre submission to approval. Responsible for addressing data requirements to regulatory authorities. This position will provide regulatory and technical expertise across the...

Role Overview The Vice President of Regulatory Strategy is responsible for providing regulatory leadership and for the planning and oversight of all regulatory submissions from pre submission to approval. Responsible for addressing data requirements to regulatory authorities. This position will provide regulatory and technical expertise across the...