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Executive Office support: serves as Chief of Staff to the VP, Head of Alexion Regulatory Affairs, supporting internal and external engagement and managing activities as part of the function’s Executive Office.
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Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Science, GMS, Biologics and Small Molecule operating units, Regulatory Affairs, and QA. Up to 20% domestic travel required.
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Associate Regulatory Affairs Specialist. Senior Regulatory Affairs Specialist. Regulatory Affairs Specialist. Cybersecurity Policy Program Director - Global Regulatory Affairs, Strategy, and Policy.
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They are seeking a Regulatory Affairs Manager (Contractor) who can provide day-to-day execution for regulatory submissions and compliance requirements. Minimum of 5+ years of experience in a Regulatory Affairs for medical devices and drug-device combination products.
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Collaborates with Government Regulatory Affairs, Network Management, Medical Economics, Benefit Administration, Provider Services, Audit, IT and Claim Operations to determine the impact of implementing policy changes.
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Demonstrated competence with payment reimbursement policy research and development within a health plan, government agency, regulatory or accreditation body. Research and monitor State/Federal regulatory policy changes and publications such as CMS, AMA, specialty societies, AAPC, Part B News for background on new code updates, impact assessments and recommend code set up parameters.
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Represent PCDS at team meetings and coordinate between PCDS and other functions including CMC, Regulatory Affairs, Clinical Operations, and Platform and Discovery Sciences. Provide strategic guidance to project teams and senior management including evaluation of conclusions and potential impact of toxicology results on program and clinical/regulatory strategy.
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The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
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Engage with senior commercial leaders in a broad range of areas outside of market access such as sales, medical, regulatory, operations, finance, supply chain, manufacturing, pharmacovigilance, external affairs, and other functions.
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In addition, the Director of Legislative Affairs is responsible for analyzing and tracking relevant legislation that has been filed by the Legislature or the Governor and monitoring changes as legislation moves through the legislative process.
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This role collaborates cross-functionally with key cross-functional partners including other GMA functions, Clinical Development/Operations, Regulatory Affairs, Corporate Communications/IR, Legal, Market Access and Commercial, and Research.
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While supporting the Chief of Staff, the Director of Legislative Affairs serves as a liaison to Legislative offices and makes sure that EOLWD and its departments are in lockstep with the administration’s vision and the mission statement for EOLWD by serving the residents of the Commonwealth, specifically employees, job seekers, employers, apprentices, union members and employees who have been injured on the job to our best ability.
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Serve as on-site physician executive in support of embedded enterprise team members for clinical compliance, risk management, and patient safety, including conduct of safety event evaluations and mitigation, and Joint Commission surveys and other regulatory site visits and inquiries (DPH, BPHC, etc.
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Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of development.
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Reporting to the Chief Medical Officer, the Senior Director of Regulatory Affairs will be responsible for the development and execution of Sails regulatory strategy and operations.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Aerotek in Cambridge, MA
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