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Previous drug development experience is preferred (e.g. Medical Affairs, Clinical Research, Regulatory, CMC, or other development related function) The Associate Director works closely together with the Oncology Business Unit (OBU) cross functional project team members, provides project management leadership on individual BD projects to ensure execution of OBU deliverables in alignment with broader cross-functional project plans.
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Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial. Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy.
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The Administrative Assistant / Office Manager position, reporting to Prime’s Associate Director of Operations, provides a central and shared resource for administrative support to Prime’s SVP of Clinical, SVP Head of Regulatory Affairs and other leadership team members as needed.
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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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Contribute towards the overall Department Regulatory Affairs and Compliance infrastructure at CCA. Promote compliance in CCA’s business operations with all Medicare and Medicaid contractual and regulatory requirements.
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Its reputation for excellence spans various legal domains, including corporate law, energy and infrastructure, finance, intellectual property, labor and employment law, litigation, regulatory affairs, real estate, and asset management, as well as investment funds.
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Role: Regulatory Affairs Associate. Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies. Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to.
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Serves as the Regional Regulatory Lead (RRL) for assigned drug development programs. Must possess at least six (6) years of relevant regulatory experience and eight (8) years of experience within the pharmaceutical or biotechnology industry.
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Industry Experience: Proven experience in clinical development, regulatory affairs, or medical affairs. The Senior Manager of Medical Writing is a high-impact role, reporting directly to the Associate Director, Director of Medical Writing, or Senior Director of Medical Writing.
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The call to action to extend and improve the lives of cancer patients is louder than ever before, and Syndax is seeking individuals who are committed to science, innovation, and excellence to join us on this mission.
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Collaborate with cross-functional teams, including clinical development, regulatory affairs, and finance, to align on trial execution plans and milestones. The Associate Director, Clinical Business Operations provides support for vendor outsourcing and financial oversight for Dyne's clinical trials.
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As part of the legal team, the Associate General Counsel will be called upon to offer legal advice and strategy on a wide variety of matters throughout the agency pertaining to the regulatory oversight of casino gaming, sports wagering, horse racing, and other matters under the Commission’s purview.
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This role will partner closely with key functions across Takeda Oncology including Translational Medicine, Clinical, Sciences, Global Regulatory Affairs, the Oncology Business Unit (Commercial and Medical Affairs), Alliance Management, Business Development, and clinical biomarker technologies.
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As an Associate Director, Global Regulatory Affairs Marketed Products you will define, develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.
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Stakeholder Collaboration: Collaborate with Indication Development Teams and cross-functional partners, including Trial Operations, medical affairs, regulatory affairs, global patient advocacy, and Global Sourcing & Vendor Alliance Management (GloSAM.
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regulatory affairs associate jobs in Cambridge, MA
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