We have other current jobs related to this field that you can find below
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Regulatory Affairs Manager
2 months ago
South Brunswick, United States Vaco Full timeManager 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...
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Regulatory Affairs Manager
2 months ago
South Brunswick Township, United States Vaco Full timeManager 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...
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Regulatory Affairs Manager
1 month ago
South Brunswick Township, United States Vaco Full timeManager 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...
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Head of Regulatory Affairs Strategy
13 hours ago
South San Francisco, California, United States Alumis Full timePosition 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...
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Head of Regulatory Affairs Strategy
5 hours ago
South San Francisco, California, United States Alumis Full timePosition 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...
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Head of Regulatory Affairs Strategy
5 days ago
South San Francisco, California, United States Alumis Full timePosition 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...
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Head of Regulatory Affairs Strategy
14 hours ago
South San Francisco, California, United States Alumis Full timePosition 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...
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Head of Regulatory Affairs Strategy
13 hours ago
South San Francisco, California, United States Alumis Full timePosition 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...
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Head of Regulatory Affairs Strategy
8 hours ago
South San Francisco, California, United States Alumis Full timePosition 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...
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Lead Regulatory Affairs Strategist
6 days ago
South San Francisco, California, United States Cytokinetics Full timeCytokinetics 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...
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Advanced Regulatory Affairs Officer
6 days ago
South San Francisco, California, United States R&D Partners Full timeR&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...
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Director of Regulatory Affairs
3 weeks ago
South San Francisco, United States Trebla Talent Full timeRole: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...
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Director of Regulatory Affairs
3 weeks ago
South San Francisco, United States Trebla Talent Full timeRole: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...
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Director, Regulatory Affairs
1 month ago
South San Francisco, California, United States tapwage Full timeAbout 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...
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Senior Regulatory Affairs Specialist
6 days ago
South San Francisco, California, United States R&D Partners Full timeR&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...
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Global Director of Regulatory Affairs
3 months ago
South San Francisco, United States Remegen Biosciences, Inc. Full timeJob 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...
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South San Francisco, California, United States Annexon, Inc. Full timeWork 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...
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South San Francisco, California, United States AbbVie Full timeCompany 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...
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Director, Regulatory Strategy
2 weeks ago
South San Francisco, United States Alumis Inc. Full timeAlumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an exceptionally motivated...
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Director, Regulatory Strategy
3 weeks ago
South San Francisco, United States Alumis Inc. Full timeAlumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an exceptionally motivated...
Manager, Regulatory Affairs
1 month ago
The Manager, Regulatory Affairs supports the association’s regulatory advocacy, outreach, and compliance assistance programs by tracking government regulatory activities, analyzing proposals and reports, representing ACD’s interests before federal agencies, and assisting members with regulatory issues and questions. The Manager is responsible for a specific portfolio of issues as assigned by the Senior Vice President, Regulatory Affairs. The Manager communicates regularly with the Government Policy and Advocacy Committee and Subcommittees. The Manager reports to the Senior Vice President of Regulatory Affairs. Responsibilities: Develops and increases expertise about the chemical distribution business and the regulations that impact member operations Develops working knowledge of the agencies that regulate the chemical distribution industry and their relevant rules and programs Reviews daily Federal Register and other regulatory publications for items relevant to ACD members Drafts regulatory comments on agency proposals that will impact member companies; gathers ACD Government Policy and Advocacy Committee and Subcommittee feedback; resolves discrepancies; and incorporates ACD positions into final comments Works with Legislative Affairs Team on issues that involve both regulatory and legislative policy and where legislative involvement could result in more positive outcomes for members Drafts regulatory reports and alerts on proposals and rules that will impact ACD members Works with Government Affairs Coordinator in analyzing various government reports such as the annual EPA Toxic Release Inventory results and in issuing materials highlighting information relevant to ACD members Selects and writes articles for the weekly ACD NewsBrief e-newsletter Writes articles for the NACD Chemical Distributor magazine and the ACD Responsible Reflections blog Addresses regulatory questions from ACD members, i.e., “help desk” function Assists in the planning and implementation of regulatory compliance training programs and materials for members Organizes, promotes, hosts, and selects topics and presenters for ACD webinars Attends hearings, listening sessions, and roundtables hosted by federal agencies Participates in ACD meetings with federal agency officials Represents ACD on industry coalitions and working groups Represents the organization in a professional manner Performs all other duties as needed Qualifications: Minimum of bachelor’s degree Minimum 1-3 years’ experience working at a federal agency or in a private sector regulatory affairs function Team player who supports coworkers Customer service mindset Ability to learn complex regulatory issues and understand their impacts on chemical distribution operations Excellent writing skills Solid presentation and speaking skills Proficiency in Microsoft software applications and other office technology utilized by ACD Total compensation for this position is market-driven and includes direct salary and comprehensive employee benefits. Qualified, interested candidates should forward a cover letter, resume, and salary requirements to chemdisthrgmail.com with “Manager, Regulatory Affairs” in the subject line. PandoLogic. Category:Marketing & Biz Dev, Keywords:Compliance Manager, Location:Arlington, VA-22203
