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QUALIFICATIONSA scientific degree with directly relevant professional experience in small molecule product development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or 10 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in defining innovative CMC regulatory strategies, and implementing at a platform level.
$237,660 - $307,560ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Preferred 10 years' experience in regulatory & scientific affairs focused on ingredient issues management in food products and packaging and/or related product categories (such as food supplements, cosmetics) with proficiency in regulatory affairs and compliance.
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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.
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State of the art fitness center on-site. 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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Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD preferred) Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Prior experience of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) A solid understanding and experience in drug development including early and late development is highly preferred.
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Senior Regulatory Affairs SpecialistWHO WE ARE:NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., develops, manufactures, and markets innovative imaging technologies and is committed to delivering fast, easy, and accurate diagnostic solutions to healthcare providers.
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This position will be responsible for expeditious coordination of the regulatory submissions in the study start-up phase to meet sponsor and institutional timelines, which is a key metric by which the sponsor will assess the site.
$5,700 - $6,800 a monthFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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The Principal PQL supports efforts to establish collaborations between Regulatory Affairs, Process Development, MS&T, Analytical Development, Site Quality (QA/QC) and Internal/External Operations to ensure regulatory compliance of GMP operations in support of the assigned program.
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You will work with cross functional groups and coordinate and collaborate with business and support teammates to provide support on regulatory responses alongside compliance, risk, strategy, and operations partners including Regulatory Relations, Regulatory Strategy, and Regulatory Affairs.
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Works with the Regulatory Affairs, Accreditation & Safety Manager to convene various QI and Safety committees and work groups, set agenda to drive desired meeting outcomes (based on contract and accreditation requirements), and ensure proper recording of committee activities.
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We advise clients on, among other things, domestic and cross border M&A, IPOs, activism, capital markets and investor relations, public and regulatory affairs, geopolitical issues, litigation, crisis, cyber, employee engagement, digital, opinion research and on broader reputation campaigns.
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Maintain clear communication channels with key stakeholders and partners (Development, Safety, Regulatory Affairs, HEOR, Medical Affairs, Precision/Molecular Medicine, and Genetics Research Center) to ensure team resources are focused on critical asset support and related initiatives.
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Temple University Hospital is a nationally respected teaching hospital on Temple University's bustling Health Sciences Center campus. As the chief clinical training site for the Lewis Katz School of Medicine at Temple University, the hospital provides a dynamic environment for high-quality care, teaching, and cutting edge research.
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Minimum of two (2) years of experience on NSEOD, CEODD or NETC Learning Center staff. We are committed to providing equal opportunity to all applicants and employees in full compliance with all applicable state and federal laws prohibiting discrimination on the basis of race, color, age, gender, sexual orientation, gender identity and/or expression, religion, national origin, disability, protected veteran status, or any other class protected by applicable state or federal law.
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The Global Head RSA H&W is the senior Regulatory & Scientific Affairs (RSA) role responsible for the ADM Health and Wellness Portfolio. This role leads the Regulatory & Scientific Affairs functional interface with the business, helps set functional priorities internally as well as externally through advocacy.
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regulatory affairs on site jobs Title: regulatory specialist Company: Berkshire Hathaway
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