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Regulatory CMC experience in authoring and review of (IND, CTA, BLA, MAA) with a drug-device combination product. Regulatory CMC experience in medical device and combination product research, development and/or manufacturing.
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If you have any questions, please contact the Office of Faculty Affairs at academic@gse.harvard.edu. By the position start date of July 1, 2025, candidates will possess a doctorate or another terminal degree in human development, psychology, sociology, anthropology, cognitive science, or a related field.
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Our parent company has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health.
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Work closely with other departments, including Commercial, Medical Affairs, Regulatory, and Legal, to align market access strategies with broader business objectives. Experience in public policy, or government affairs within the pharmaceutical or biotechnology industry, with a strong focus on rare diseases is highly preferred.
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A Bachelor’s degree in a related field with at least 8-10 years of experience in CMC operations, regulatory affairs, or quality assurance within the pharmaceutical or biotechnology industry.
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Associate) Director, US Regulatory Affairs, Advertising & Promotion - Permanent - MA, NC, GA Proclinical is seeking a (Senior/Associate) Director, US Regulatory Affairs, Advertising & Promotion for a large global pharmaceutical company with locations in Georgia, North Carolina and Massachusetts.
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Lead Patient Advocacy and Engagement; develop and execute a plan to amplify corporate and medical affairs goals to patient advocacy groups for THB0335 and future assets. MD, PharmD, or PhD with 15+ years of related experience, including relevant Medical Affairs strategy experience.
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Alumni Affairs and Development is a dedicated team supporting Harvard’s advancement activity through front-line fundraising, alumni and volunteer engagement, technology, prospect management and research, business process, events, communications, and many other areas.
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Minimum of 3 years of experience in regulatory affairs within the biotechnology or pharmaceutical industry. Certification in Regulatory Affairs. Job Summary: Instrumental in navigating the complex regulatory landscape of biotechnology products.
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Center 2 (19050), United States of America, McLean, VirginiaManager, Data Science - Consumer Identity Machine Learning. Consumer Identity ML is the data science and machine learning team inside Capital One’s AI foundation organization.
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Job Requirements REQUIRED: bachelor’s degree with coursework in public policy, public administration, international development, international affairs, economics, or a related field; at least four years of relevant work experience; and demonstrated academic interest in rigorous evidence about poverty alleviation.
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Work closely with R&D, Program Management, CMC, Regulatory Affairs, Patient Safety and Pharmacovigilance, and others to support the planning and execution of non-clinical safety studies at appropriate stages to facilitate the progression of novel therapies through development without delay.
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This opportunity will offer you the chance to grow your Regulatory Affairs CMC expertise across a range of disciplines such as nucleic acid therapeutics, lipid-nanoparticle drug delivery, viral delivery systems, and a range of cell therapy products.
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Sr. Regulatory Project Manager (Biotech or Pharmaceutical exp.) PLEASE NOTE: Candidates need a minimum of 6 years’ experience in either the Biotech or Pharmaceutical industry along with experience developing and implementing best practices for preparing major global regulatory filings.
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G, clinical operations study team members, regulatory affairs, quality assurance, and information technology) to ensure TMF compliance and quality) Manage the Trial Master file in compliance with regulatory requirements and company SOPs.
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consumer affairs jobs Title: regulatory affairs in Cambridge, Anoka, Minnesota
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