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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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3-5 years relevant experience in at least one of the following fields: Outcomes Research, HE, Clinical Research, Epidemiology, Health Policy. Medical Affairs: TA Heads, Executive Directors, CMT leads, ESMA leads, Senior Medical Directors/CMT members, HEOR Leaders.
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Work with Director, Medical Director and Associate Directors of Administration and Clinical Affairs to ensure customer response and timely delivery of disability determination processes and outcomes.
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Clinical Affairs/Novel Biomarker Discovery: Focus on early feasibility and novel biomarker discovery. Regulatory Affairs Certification preferred. This includes execution of defined analytical and clinical studies to support design changes and if needed, registration and submission to regulatory bodies.
$20 - $27 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This position independently manages relationships with internal (CSPV, Regulatory, Clinical, Medical Affairs, HEOR and other stakeholders to ensure expectations are clearly defined and met across participating teams) and external stakeholders.
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Support preclinical and clinical global regulatory strategy development, including considerations for rare diseases in pediatric and adult populations. You will support global regulatory activities for Entrada's pipeline, including preclinical and clinical-stage assets.
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Lead cross-functional teams comprised of members from diverse subject areas - including, but not limited to - clinical operations, medical, regulatory affairs, biometrics, safety, quality, and supply - to facilitate transparent communication and knowledge sharing.
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At least eight (8) years of experience in auditing and/or experience in a senior advisory role in quality management and/or at least twelve (12) years of professional experience in the pharmaceutical industry in a relevant Medicine function (Pharmacovigilance, Regulatory Affairs, Medical Affairs, Clinical Operations, Biostatistics and Data Management, computer system validation.
$163,000 - $248,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Partner with Research, Regulatory Affairs, Medical Affairs, Biometrics, Clinical Operations, Safety, Quality Assurance, Product Development, Business Development, and Management to formulate and implement comprehensive clinical trial plans.
$234,000 - $286,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Role: Associate Regulatory Affairs. Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance, including familiarity with US Certificate of Pharmaceutical Product (CPP) process.
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The position requires sustained, concise communication with departmental team leaders, project managers, Quality Assurance, and CMC Regulatory Affairs so a firm command of the English language as well as excellent verbal and written communication skills, and a knowledge of computer applications and data acquisition systems are essential.
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The Associate Director, Regulatory Affairs (CMC) possesses strong leadership skills, broad knowledge of multiple aspects of regulatory affairs (beyond CMC) across all phases of drug development, and a deep understanding of global CMC regulations, including GMP and region-specific guidelines, especially as they relate to gene therapies.
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As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.
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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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The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager's gene therapy products.
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