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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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10+ 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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May oversee and direct the work of other Regulatory Affairs professionals. Serves as a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.
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The Analyst II, Regulatory Affairs has experience with and performs key centralized complex and difficult regulatory activities for the Compliance Department. Candidate must have knowledge of and experience with state and Federal regulatory and other requirements and practices related to Covered California, Medicare and Medi-Cal (Medicaid), Title 19 (USC)/Title 29 (USC and CCR), Title 22 (CCR), Title 28 (CCR), Title 42 (USC and CFR), CA Welfare and Institutions Code, and CA Health and Safety Code.
$71,572.8 - $93,038.4 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Minimum of 5 years of experience in regulatory affairs, specifically within the dietary supplements or related industries in the U.S. market. As our Regulatory Affairs Manager, you will play a crucial role in our product development team by ensuring that all new and existing products comply with regulatory standards in the United.
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Regulatory Affairs Manager (Medical Device/Cosmetic) - Long Beach, California page is loaded. Regulatory Affairs Manager (Medical Device/Cosmetic) - Long Beach, California. Serves as the internal subject matter expert for international regulatory affairs on assigned projects/regions, including labeling review.
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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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To do these effectively, the Analyst III – Policy & Regulatory Operations must have a demonstrated understanding of IEHP business operations and responsibilities of various departments in Health Services, Quality Systems, Provider Services, and Member Services; subject matter expertise of these departments’ policies and procedures and the regulations that drive their business operations and demonstrated ability to effectively and consistently manage multiple projects and priorities concurrently.
$80,059.2 - $106,059.2 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
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Support regulatory inquiries from the CFPB, FDIC, other federal regulatory authorities and bank partners. Experience handling regulatory matters and have prior relationships with relevant regulators at the CFPB, FDIC, OCC, and other relevant state and federal agencies.
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To continue our success, we currently have an exciting opportunity for a Regulatory Affairs Specialist. 3-5 years experience in Regulatory Affairs. Assess and ensure compliance of finished products formula and raw materials spects with ANZ regulatory requirements.
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OPPORTUNITY Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
$205,000 - $260,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of development.
$169,400 - $266,200 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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A thorough understanding of the complex Regulatory, Development and Medical Affairs requirements in oncology, as well as the emerging paradigm for cell & gene therapy. Precigen is advancing an exciting pipeline of novel cell and gene therapy products and to further our efforts we are seeking an Executive Director, Medical Affairs who will be instrumental in creating and building the global medical affairs function at Precigen for our first commercial launch.
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The Head of Regulatory Affairs US will report to the Head of Legal Affairs US. This position will handle a wide range of regulatory affairs matters, including providing legal advice and counsel across various sectors, functions, and business units both in the United States and internationally.
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Title: regulatory affairs Company: The Better Being Co
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