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Regulatory Affairs Associate
6 days ago
Cytokinetics South San Francisco, United StatesReporting to the Senior Director of Regulatory Affairs, the Regulatory Affairs Associate is responsible for coordination and preparation of a variety of regulatory submissions and for assisting the Regulatory Affairs team with various projects. · **Responsibilities** · - Prepare ...
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Regulatory Affairs Manager
1 week ago
AbbVie South San Francisco, United States**Company Description** · **Job Description** Key Responsibilities** · - Responsible for providing regulatory strategy & support for global development. · - Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions ...
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Associate Director, Regulatory Affairs
3 weeks ago
Cytokinetics South San Francisco, United StatesReporting to the Senior Director, Regulatory Affairs, the Associate Director of Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies. · **Responsibilities** ...
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Director, Regulatory Affairs
2 weeks ago
Maze Therapeutics South San Francisco, United StatesJob Description · Job DescriptionThe Position: · Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a stra ...
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Director, Regulatory Affairs
3 weeks ago
Maze Therapeutics South San Francisco, United States Full timeThe Position: · Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expe ...
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Director, Regulatory Affairs
3 weeks ago
Mazetx South San Francisco, United StatesBecome a genetic navigator. · Our mission is to discover new genetic insights and translate them into new precision medicines. With an unparalleled commitment to changing the way people with severe diseases are treated, our team is at the forefront of accelerating our understand ...
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Sr. Director Regulatory Affairs
3 weeks ago
Life Science People South San Francisco, United StatesSenior Director of Regulatory Affairs · Menlo Park, CA · Life Science People are currently working with an exciting client, looking for a Sr. Director Regulatory Affairs professional with a strong background in oncology submissions. · My client is looking for someone to come in ...
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Regulatory Affairs Analyst
1 week ago
University of California San Francisco San Francisco, United StatesThe analyst works independently, under the direction of the Regulatory Affairs Manager, to review cooperative and industry-sponsored protocols, revise local informed consents (ICFs), and submit review packets (protocols, ICFs, and other required documents) to the UCSF IRB and ext ...
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Regulatory Affairs Director, Oncology
1 week ago
AstraZeneca, plc South San Francisco, United StatesWithin Oncology Regulatory Science Strategy and Excellence (ORSSE), we bring hope and solutions to patients with unmet needs. We work across our ground-breaking pipeline and the business to get medicines to patients as efficiently and optimally as po Regulatory Affairs, Director, ...
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Global Director of Regulatory Affairs
3 weeks ago
Remegen Biosciences, Inc. South San Francisco, United StatesJob Description · Job DescriptionORGANIZATION · RemeGen 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, Mary ...
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Senior Director, Regulatory Affairs
3 weeks ago
ALX Oncology Inc. South San Francisco, United StatesALX Oncology is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, evorpacept, is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 bind ...
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Senior Associate, Regulatory Affairs
1 week ago
Allogene South San Francisco, United StatesAbout 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 T) products for cancer and autoimmune disease. Led by a management team wi ...
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Regulatory Affairs Associate
4 days ago
Cytokinetics South San Francisco, United StatesPrepare and/or coordinate and comply routine regulatory submissions and other correspondence in accordance with regulatory agency regulations and guidelines Review regulatory documents to ensure that all submissions are complete, accurate and meet re Regulatory Affairs, Regulator ...
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Regulatory Affairs Consultant
1 week ago
People With Chemistry South San Francisco, United StatesOur client is seeking a high level Regulatory consultant specializing in Immunology. In this role, you will lead strategic regulatory efforts. In addition, act as Global Regulatory Lead, shape global expansion and clinical registration strategies. · Responsibilities: · •Devise g ...
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Regulatory Affairs Manager
2 weeks ago
Tessenderlo Kerley South San Francisco, United StatesJob Description · Role Description: · Tessenderlo Kerley, Inc. is a manufacturing company with sales in the United States, Canada and over 50 other countries. As the crop protection division of Tessenderlo Kerley, Inc., NovaSource delivers a portfolio of proven and effective crop ...
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Regulatory Affairs Manager
1 week ago
AbbVie South San Francisco, United StatesCompany Description · AbbVie'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 ...
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Regulatory Affairs Manager
2 weeks ago
AbbVie South San Francisco, United StatesJob Description · Job DescriptionCompany Description · AbbVie'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 acr ...
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Regulatory Affairs Manager
2 weeks ago
AbbVie South San Francisco, United States Full time· Company Description · AbbVie'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 ar ...
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Head of Regulatory Affairs, Oncology
3 weeks ago
Ascendis Pharma Palo Alto, United StatesHybridPalo Alto, California, United StatesOncology, Regulatory, OncologyFull time1404 · Description · We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing programs in Endocrinology Rare Disease, and Oncol ...
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Executive Director Regulatory Affairs
2 weeks ago
Barrington James South San Francisco, United StatesExecutive Director Regulatory Affairs · I am excited to announce that we are partnering with another biologic oncology company who has a multi stage and deep pipeline of products that they are trying to bring to market. If your looking to join a company who is on the verge of sev ...
Vice President/Senior Vice President, Regulatory Affairs - South San Francisco, United States - Meet Recruitment
Description
Vice President/Senior Vice President, Regulatory AffairsThis range is provided by Meet. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Vice President or Senior Vice President, Regulatory Affairs & Quality Assurance
Meet has engaged on a search for a confidential search for a VP/SVP of Regulatory and Quality with one of our biotech clients.
Our client is focused in the Heme/Onc space - you'll be reporting into C-Suite and will be heading up Reg and Quality for the organization.
Additional details can be provided via phone call.Key Responsibilities
Lead Regulatory Affairs and Quality Assurance functions
Manage all aspects of Regulatory submissions (IND/CTA, NDA/BLA/MAA)
Manage FDA (and ex-US Health Authority) interactions
Key Qualifications
20+ years of industry experience, minimum 10 years of management/leadership experience
Oncology experience required
Full development cycle experience required (pre-IND through commercial)
Startup experience highly preferred
Please reach out to Ryan Moran to setup a confidential conversation:
:
Seniority level
Seniority level
Executive
Employment type
Employment type
Full-time
Job function
Job function
Strategy/Planning, Writing/Editing, and Science
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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