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15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
$51,824 - $63,600 a yearFull-timeRemoteExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The Regulatory Affairs Manager will work out of our Maple Grove, MN location for our Electrophysiology division. Regulatory Affairs Manager - Electrophysiology page is loaded.
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As a key member of our legal department, the Senior Manager of Regulatory Affairs/In-House Counsel will play a crucial role in managing regulatory compliance, with a primary focus on collections and litigation.
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Allogene is seeking a Senior Director, CMC Regulatory Affairs to provide support for products under development and lead CMC product strategy and provide regulatory direction to quality, manufacturing/tech ops and supply chain teams.
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Serve as liaison for internal regulatory bodies (IRB, IBC, IACUC, Regulatory Affairs, etc.) Experience with regulatory affairs in an academic research environment. Demonstrated knowledge of regulatory guidelines (IRB, IACUC, MUA, etc.
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As the newest Regulatory Affairs Manager, you will be responsible for registering current and newly acquired crop protection products in the U.S. and other regions (Asia/Pacific, Latin America, Africa, Europe, and Canada.
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Under the supervision of a Global Virology Regulatory Affairs liaison, the intern will work with various team members in the Gilead Foster City team to support regulatory submissions in the United States and potentially other countries for marketed and investigational products.
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QUALIFICATIONSA scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
$295,290 - $382,140ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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Supports the Senior Director of Federal Affairs by identifying emerging federal legislative and regulatory issues that may impact Salt River Project's electric customers, water shareholders, employees, and elected officials; assist in the development and implementation of governmental affairs strategies to achieve corporate goals and objectives, including but not limited to the following areas: energy, water, environmental and tax policies.
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Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
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Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.
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Reports to: Executive Vice President and Managing Director, Chief Counsel, Head of Global Regulatory Affairs. Position Title: Counsel/Senior Counsel, Regulatory Affairs (position title and compensation is commensurate with experience.
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Recruiting Practice Director, Regulatory Affairs (Pharma) Experience placing Regulatory Affairs professionals in CMC, Ad Promo, Labeling, Regulatory Strategy, etc. Cultivating long-term partnerships with key stakeholders in Regulatory Affairs.
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