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Balance reporting requirements to multiple constituencies including; Centene Corporation regional vice president, state health plan president, chief operating officers and Corporate regulatory and government affairs staff.
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In conjunction with the AVP, Medical Affairs NA - Biologics and Market Access, will be the responsible member of the Sun Pharma medical department in regulatory interactions, ISS and expert advisory board meetings, external professional societies, seminars, and conventions.
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The incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations at Gilead. In addition, the Sr Director will be accountable for leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally.
$237,660 - $307,560 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Regulatory Affairs Specialist III (Current Employee) Hercules, CA. The Senior PCR Production Chemist responsible for the fermentation, purification, and formulation of materials used in PCR Production.
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Lead the execution and evolution of the integrated launch plan, coordinating with supply chain, regulatory affairs, market access, HEOR, medical affairs, and other functions. As a pivotal member of the rare disease team, the Global Marketing & Commercial Lead for Rare Disease will report to the General Manager and drive the execution of a robust commercial strategy for our portfolio, initially focusing on PA and MMA. This strategic role requires collaboration with multidisciplinary teams across R&D, Medical Affairs, Value and Access, and Supply Chain to ensure cohesive efforts within Moderna.
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Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience. Within Global Regulatory Affairs, the CMC organisation provides regulatory leadership to CMC teams encompassing Global Supply Chain (GSC), Technical and Quality representatives and Local Operating Companies to enable an uninterrupted supply of our medicines to patients.
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Minimum of ten (10) years at a studio feature film business affairs department or major entertainment law firm. The position of Vice President of Business & Legal Affairs is responsible for negotiating and structuring complex development, production, distribution, rights acquisition, and other agreements for Skydance's Feature Film Business & Legal Affairs group.
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You Have: 3+ years direct experience with federal regulatory examinations (FDIC, FRB, OCC, or CFPB) and bank partnership lending models. You will work with partners in legal, operations, compliance, finance, data analytics and engineering, product and other teams, to ensure that Block is compliant with applicable requirements and obligations while, to the extent possible, streamlining regulatory impact and facilitating innovation.
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In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
$145,400 - $269,400 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Cross-Functional Collaboration Collaborate with internal stakeholders, including clinical operations, scientific affairs, data privacy, information security and quality, to define vendor requirements and ensure alignment with study objectives and regulatory requirements.
$95,000 - $135,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Initial draft authoring of scientific content for Common Technical Document (CTD) Quality sections and responses to health authority questions aligned with regulatory strategy for cell therapy clinical CMC regulatory submissions based on high quality technical reports.
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Collaborate with Clinical Development, Regulatory Affairs, and other key departments to promote a robust drug safety culture. Lead and author key pharmacovigilance documents, including medical safety assessments and regulatory responses, applying regulatory guidance for safety surveillance and document authorship.
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Bachelor's Degree in a related field and 6+ years of related work experience (including data analytics, data management, health economics, medical affairs, clinical risk, clinical trial operations, clinical safety, quality assurance or regulatory affairs) OR advanced degree (PhD, research-based MS, MD, RN/DVM) in a related field with 4+ years of related work experience.
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Work closely with individuals from Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA endpoint strategies are consistent with and correctly executed to support the product strategy.
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Firm Type: Law Firm, Experience: 5 Years, A law firm in Washington, DC is seeking an Electric Regulatory Associate Attorney with 5+ years of experience. Draft legal memoranda, pleadings, and other documents for regulatory proceedings.
$150Full-timeExpandApply NowActive JobUpdated 5 days ago
regulatory affairs jobs Company: Tjx Companies Inc in East-hartford, Connecticut
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