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Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director. Reporting directly to the Senior Director CMC of Regulatory Affairs, the (Associate) Director of Regulatory CMC will be responsible for the development of regulatory CMC submissions.
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The Associate Director of Regulatory Operations is responsible for the assembly, publishing, QC, submission, and archiving of regulatory filings to global Health Authorities (HA) in an efficient and timely manner.
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This position requires excellent interpersonal and matrix leadership skills to support effective partnerships with key internal and external stakeholders including global/regional/local HEOR leaders, Department Heads, TA Heads, CMT Leads, Development, Regulatory Affairs, and Market Access.
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Reporting to the Associate Director, Medical and Regulatory Writing, the Senior Manager, Regulatory Technical Writer will be a key member of the Clinical Development organization and interface with cell therapy clinical, nonclinical, and manufacturing research personnel in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, tech transfer recipients, journal editors, NIH, clinical trial sites/investigators.
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Reporting to the Director, Medical Writing, within Regulatory Affairs, the Associate Director of Medical Writing will be responsible for timely and accurate medical writing deliverables, and effectively collaborate with cross-functional teams.
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Our teams include Communications, Community Impact and Investment, Community Finance, CRA Strategy and Program Management, the Government and Political Affairs Group, Regulatory Relations, and Strategy and Engagement.
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Equivalent work consisting of at least eight (8) years of experience working in the research regulatory field in a clinical research or scientific setting, an institutional review board office, research administration, or regulatory affairs in a pharmaceutical and/or medical device company.
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Proven track record of being able to successfully interact with all levels of area, affiliate and internal authority across divisions (including Global Commercial Leaders, Forecasting, Clinical Development, HEOR, Medical Affairs and Regulatory, as well as peer equivalents in other market access teams and the market access community as a whole.
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DescriptionThe Associate General Counsel (Senior Director of Legal) leads the credit union’s Enterprise Governance and Legal Affairs department which is responsible for corporate policy management, the review of all legal process served, and providing general legal support to all business units.
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This role requires close collaboration with specialists in various areas including veterinary science, bacterial process development, vaccine formulation, manufacturing, bioinformatics, intellectual property, assay development, immunology, animal experimentation, pathology, regulatory affairs, and marketing.
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Under the general direction of the Provost and Vice President for Academic Affairs, the Associate Vice President (AVP) for Grants, Research, and Sponsored Programs (GRaSP) primarily focuses on collaboratively developing and implementing a strategic agenda to secure and manage extramural funding and elevating the profile of grant writing and scholarly activity.
$9,167 - $29,425 a monthExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The role involves close partnership with project Clinical Scientists and extensive collaboration with colleagues across disciplines, including Discovery, Translational Science & Medicine, Clinical Pharmacology, Biostatistics, Data Science, Medical writing, Clinical Operations, Global Medical Safety, Regulatory Affairs, Quality, Medical Affairs, Commercial and Market Access.
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We are currently seeking a Regulatory Affairs Associate Director to join our growing regulatory team. Associate Director - 5 – 7 years of experience in Regulatory Affairs (strong preference for experience in oncology) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment.
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Join Takeda as an Associate Director, Global Regulatory Affairs CMC - Marketed Products where you will be a GRA CMC member on Regulatory, Pharmaceutical Development, and Commercial project teams throughout commercial lifecycle.
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GEICO’s Government and Regulatory Affairs team is looking for experienced Government Relations individuals to join our team to advance the Company’s legislative and regulatory agenda.
$132,000 - $220,000Full-timeExpandApply NowActive JobUpdated 4 days ago
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