Regulatory Affairs Manager

Manager Regulatory Affairs Preparation and review of various regulatory submissions to the appropriate Regulatory Agency. Regulatory submissions, initiation review of change controls and labeling. Collect and review documentation required for filing and track the activities for timely submission. Act as Regulatory Affairs team member in projects as well as...

Manager Regulatory AffairsPreparation and review of various regulatory submissions to the appropriate Regulatory Agency. Regulatory submissions, initiation review of change controls and labeling. Collect and review documentation required for filing and track the activities for timely submission. Act as Regulatory Affairs  team member in projects as well as...

Position OverviewSalary: $220,000 to $250,000 annuallyAlumis Inc. is a pioneering company in precision medicine, dedicated to enhancing the lives of individuals suffering from autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous patients with immunologic conditions still face significant challenges. Our mission is to...

Position OverviewAlumis Inc. is a pioneering company dedicated to enhancing the lives of individuals affected by autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous patients with immunologic conditions still face significant challenges. Our mission is to fundamentally improve outcomes for these individuals. We are in...

Position OverviewSalary: $220,000 to $250,000 annuallyAlumis Inc is dedicated to revolutionizing the treatment landscape for patients suffering from autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous individuals with immunologic conditions still face significant challenges. Our objective is to profoundly alter the...

Position OverviewSalary: Alumis Inc is dedicated to revolutionizing the treatment landscape for patients suffering from autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous individuals with immunologic conditions still face significant challenges. Our objective is to dramatically improve patient outcomes. We are in...

Position OverviewAlumis Inc. is a pioneering company in precision medicine dedicated to improving the lives of individuals suffering from autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous patients with immunologic conditions still face significant challenges. Our mission is to fundamentally enhance the outcomes for...

Position OverviewAlumis Inc is dedicated to revolutionizing the treatment landscape for patients grappling with autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous individuals with immunologic conditions still face significant challenges. Our objective is to fundamentally enhance patient outcomes. We are in search of...

Cytokinetics is a pioneering biopharmaceutical organization specializing in the cardiovascular sector, dedicated to the innovation, development, and commercialization of groundbreaking muscle activators and inhibitors aimed at addressing severe conditions where cardiac muscle functionality is impaired. As a frontrunner in muscle biology and performance...

R&D Partners is in search of a Senior Regulatory Affairs Consultant. Key Responsibilities: Support ongoing marketed products by reviewing engineering modifications, promotional materials, labeling, and documentation to ensure compliance with both US and international regulatory standards.Draft and maintain product technical files while overseeing compliance...

Role:Director, Regulatory Affairs Bay Area/HybridCompany Description:This precision oncology biotech is advancing next-generation targeted therapies. Having recently emerged from stealth mode with substantial funding, this pre-IPO company is pioneering new frontiers in antibody engineering and its working! Their innovative approach has already earned FDA...

Role:Director, Regulatory Affairs Bay Area/HybridCompany Description:This precision oncology biotech is advancing next-generation targeted therapies. Having recently emerged from stealth mode with substantial funding, this pre-IPO company is pioneering new frontiers in antibody engineering and its working! Their innovative approach has already earned FDA...

Job Summary:This position will determine the current regulatory requirements and strategies for Terumo’s devices and projects and define information and actions necessary to meet requirements. Determining strategy and requirements within the position will vary in complexity based on scope and different regulatory markets. This position will prepare...

About Allogene:Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR TTM) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of...

R&D Partners is looking for a Senior Regulatory Affairs Specialist III. Key Responsibilities: Support for marketed products, including reviewing engineering modifications, labeling, promotional content, product alterations, and documentation to ensure compliance with both US and international regulatory standards.Draft and maintain submissions and product...

Job DescriptionJob DescriptionORGANIZATIONRemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein...

Medical Affairs Manager12+ MonthsTitusville, NJ (Hybrid OR Remote can be considered)• Schizophrenia, Psychiatry, or Neuroscience related training &/or experience is preferredThe Associate Medical Director, Schizophrenia has responsibility for the design and execution of US Medical Affairs Schizophrenia initiatives (i.e., medical education programs,...

Work LocationCorporate Headquarters (South San Francisco, CA) – HybridPosition SummaryThis role provides global regulatory leadership and direction to support the development, registration, and life-cycle management of innovative programs within the Annexon portfolio. Responsibilities include developing regulatory strategies and detailed plans to meet...

Job Description: The Associate Medical Director, Schizophrenia has responsibility for the design and execution of US Medical Affairs Schizophrenia initiatives (i.e., medical education programs, advocacy initiatives, evidence dissemination, and evidence generation). Strong collaboration with internal and external business partners including regulatory, brand...

Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...