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Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director. For Director, 10+ years experience in CMC Regulatory Affairs with prior pharmaceutical industry experience.
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Medical and Scientific Affairs serves a critical internal leadership and customer-facing support role, including pre- and post-market partnership to functions such as product management, sales and marketing, R&D, Clinical Affairs, Regulatory Affairs, Quality Assurance, Innovation, Strategy, Pharmaceutical Partnerships (Companion Diagnostics), and Technical Support.
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This is what you will do:The Senior Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (RCMC) will provide strategic as well as operational leadership of global CMC activities related to Cell & Gene Therapy (GCT) leading to successful registration and life-cycle management of unique and technologically complex products.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Position Summary and Overview The Medical Director, Global Pathology Solutions will serve key roles in a growing Medical and Scientific Affairs function that provides leadership on medical, scientific, and clinical decisions related to the overall Leica Biosystems business strategy.
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Fifteen (15) years of experience in Regulatory Affairs and Quality experience in the biotechnology, medical devices, or pharmaceutical industry with increasing responsibility (including interfacing with FDA and other regulatory agencies in development and commercialization of new medical technologies.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The Medical Director, Global Pathology Solutions will support the development and execution of the Medical and Scientific Affairs functional strategy. Experience in the development of in vitro diagnostic products including interactions with regulatory agencies.
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Engage regularly with colleagues within Corporate Communications (Social Media & Corporate Brand Storytelling); across External Affairs (Patient Engagement & Advocacy and Government Affairs); and cross-functionally in Employee Communications, Market Access, Medical Affairs, HEOR, Legal, Regulatory and Investor Relations to understand each functions objectives and drive an aligned approach to product communications and stakeholder message harmonization.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Regularly interfaces with team members in R&D including Biostatistics and SAS Programming staff, Data Management, clinical research and operations teams, regulatory affairs, clinical pharmacology, medical writing, medical affairs and quality management.
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs Pharmaceuticals. Minimum of 15 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Regulatory Sciences.
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We’re a leader in staffing Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, HEOR, Market Access, and Sales & Marketing roles. TMAC’s direct-hire service, formerly known as TMAC Direct, is an award-winning executive search firm that specializes in permanent placement services for the Pharmaceutical, Biotech, Diagnostics, Device, and Life Science Research industries.
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Forms cross-functional alliances with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by providing SMEs to these functions and project teams.
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Minimum of 15 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Regulatory Sciences Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e.g. US FDA, EU, PMDA, NMPA, WHO.
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Reporting directly to the head of medical affairs, the Senior Director will play a pivotal role in leading the development and execution of strategies to generate and leverage real-world evidence to support the launch, development, market access, and commercialization of Aerovate's novel cardiopulmonary therapy.
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Develop effective collaborations with project leaders and projects team members, including research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision medicine and development operations.
$161,600 - $269,400 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Serve as cross-functional strategic leader on all Medical and Clinical work streams in the oncology portfolio, including clinical pharmacology, statistics, clinical operations, regulatory affairs, and preclinical science and translational medicine.
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