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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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Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs. Negotiates cross-functionally, successfully motivates and influences (Clinical Development, Regulatory Affairs, CMC, QA, Pharmacovigilance, etc.
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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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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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Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs.
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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. The candidate should possess an in-depth understanding of safety pharmacology, investigative and regulatory toxicology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
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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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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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This role functions in a matrix team environment, interacting with several key stakeholder groups including Clinical Development, Pharmacovigilance, Regulatory Affairs, Quality Assurance, Manufacturing, Commercial, Medical Affairs, Research, and Legal.
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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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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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Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression. Collaborate with regulatory affairs to support regulatory submissions and inspections.
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Contribute to the development of real-world evidence strategies for post-marketing programs, and health economics and patient outcomes research initiatives. Experience in epidemiology, health economics, or real-world evidence.
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regulatory affairs jobs Title: principal consultant Company: Parexel in Cambridge, MA
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