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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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The Senior Regulatory Affairs Manager also develops and maintains familiarity with key health plan operational processes to inform our advocacy efforts. The Senior Regulatory Affairs Manager, in collaboration with the Director, LRAC, will lead the federal advocacy efforts through trade associations, including America's Health Insurance Plans (AHIP.
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Support Danaher Diagnostic Operating Company Medical and Scientific Affairs and Government Affairs organizations on their strategy so that it maximizes patient impact at scale. Prior roles in industry Medical and Scientific Affairs and/or Government Affairs functions a plus.
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The Manager/Senior Manager of CMC Regulatory Affairs will be responsible for supporting commercial CMC and GMP activities for contracted manufactured products and Alkermes' European office.
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The Principal Analyst in the Regulatory Services Management team ("RSM") in FINRA's Department of Market Regulation and Transparency Services ("MRTS") is responsible for performing a wide variety of tasks in support of establishing and maintaining controls for RSM standard and non-standard reports to be delivered to the Regulatory Service Agreement (RSA) Exchanges and other FINRA customers, as applicable.
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The Associate Director of Regulatory Affairs will oversee daily regulatory affairs activities, including the areas of clinical research, CMC, regulatory operations, nonclinical study requirements, and regulatory compliance to support the successful development, approval, and marketing of Marengo products.
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Bachelor's Degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field. The Associate Director, Regulatory CMC executes multi-product global regulatory CMC strategies for cell therapy combination investigational and marketed products.
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Identify new research opportunities beyond the OpCo or Platform core R&D efforts and support strategic IP management, as well as guidance around FDA and international regulatory matters partnering with Platform and OpCo legal counsel.
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Bachelor's degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 10 years' experience in drug development/regulatory affairs and a minimum 8 years in CMC regulatory affairs.
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The College's schools, departments, and programs—with disciplines ranging from economics and history to English, urban affairs and international affairs, form an interdisciplinary group of scholars with global perspectives and a culture of inclusion.
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Additionally, the VP, Regulatory Affairs and Quality will be responsible for hiring a Director, Regulatory Operations, to report to them. The Vice President, Regulatory Affairs and Quality will work collaboratively with colleagues across the company, and with outside partners, to design and execute global registrations strategies for all Xilio products, including initial regulatory efforts on pipeline programs.
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POSITION SUMMARY: Under the direction and guidance of the Associate Vice President, Career and Digital Strategy, the Senior Director of Industry and Employer Engagement will develop and lead the implementation of a comprehensive strategic plan that drives engagement with industry, including employers, recruiters and alumni in coordination with Academic Affairs, the International Career Center (ICC) and Alumni Affairs.
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4-5 years of experience in regulatory compliance, risk management, or audi t within the financial services industry , with a focus on IT asset management or technology controls preferred. Collaborate with Legal and Compliance teams to interpret regulatory guidance and assess the impact of regulatory changes on IT asset management practices, ensuring timely implementation of necessary controls and processes.
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O Investigate and document reports of non-compliance involving laboratory animal care and use, including preparation and submission of reports and other documents to the IACUC, IO, and regulatory and accrediting agencies when indicated.
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Massport's Capital Programs & Environmental Affairs Department is dedicated to advancing the vision of transforming our industry through groundbreaking approaches, consistently delivering "best-in-class" infrastructure projects that create exceptional value and surpass the expectations of our valued clients and customers.
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regulatory affairs jobs Title: principal consultant in Cambridge, MA
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