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The AD/Director, Regulatory Affairs CMC (Chemistry, Manufacturing and Controls) will be responsible to ensure that Zenas is executing global regulatory CMC strategies to support clinical development and commercialization readiness of biologic drug products and drug/device combination products.
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Advanced Degree (Master’s or Doctorate Degree) in science, law, health policy, regulatory affairs or engineering and 2+ years of experience in life sciences, biopharmaceutical, medical device, biologics regulatory or closely related field.
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The Vice President / Senior Vice President & Global Head of Regulatory Affairs will report directly to the Chief Medical Officer of this clinical-stage biotechnology company developing ground-breaking cancer therapies and lead Global Regulatory Affairs for the company.
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The company has a really strong portfolio in dermatology and rheumatology and requires and experienced Medical Affairs leader to plan for the launch of important new medicines. A large pharma business has a new role to lead its Medical Affairs function in its Immunology franchise.
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Strategic and thought leadership experience in medical affairs and Neuroscience. Primary DutiesLeads and expands Neuroscience Therapeutic Area (TA) including hiring of Global Medical Affairs (GMA) professionals covering different therapeutic indications and devising/implementing multi-year strategic plan for priority development asset including full budgetary responsibilities.
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US medical affairs, marketing, market access global value and access teams, commercial. Actively collaborate with cross-functional teams (e.g., US medical affairs, marketing, market access global value and access teams, commercial) to prioritize projects towards achieving effective utilization of resources.
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Regulatory Affairs Expertise: Collaborate with regulatory bodies such as the FDA, EU agencies and international counterparts. Position Summary As the Vice President of Clinical Affairs, you will play a crucial role in the strategic development of our clinical research and trials.
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The Associate Director Strategic Planning & Execution, US Medical Affairs is responsible for the execution of strategic initiatives within the US Medical Affairs organization and will partner with TA Leadership teams and cross functionally to execute on projects in line with the functions overall strategic goals.
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The Director, Regulatory Affairs helps drive forward our regulatory strategy and operational activities related to Dyne’s muscle disease programs. With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed toovercome limitations in delivery to muscle tissue.
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Through a comprehensive understanding of the diagnostic and care landscape, the candidate will closely collaborate with the International Business Unit (IBU) marketing and medical teams, Government Affairs, and International Communication teams to execute, in partnership with the local affiliate teams, integrated solutions designed to remove obstacles to optimal patient pathways.
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Instructional areas included, but are not limited to, clinical trial management, new drug development, biologics, medical device regulations, the development and marketing of medical products/technology, law and intellectual property, international regulatory affairs, and science writing.
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This role will work closely with a cross-functional group that includes Commercial, Market Access, Global Medical Affairs, US Public Affairs, Corporate Communications, Legal, Compliance (OBIE), Regulatory, Research & Development, HR and Finance.
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Reporting to the Executive Director of Regulatory Affairs, you will have the opportunity to oversee the implementation of regulatory strategies for Apogee’s products in collaboration with project teams and the regulatory affairs department.
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The Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development. Draft and/or modify applicable SOPs and/or other written practices relating to the regulatory affairs function.
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Responsible for performing the accurate and detailed medical review of complex advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs. Collaborates with clinical development on Medical Affairs support of priority trials.
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Title: affairs Company: Turnstone Biologics in Waltham, MA
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