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Job Description PharmaLex is one of the largest worldwide providers of consulting services in the following focus areas: Quality Management & Compliance; Development Consulting & Scientific Affairs; Regulatory Affairs; and Pharmacovigilance, Epidemiology and Risk Management.
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Senior Regulatory Affairs Specialist. Manage preparation of regulatory documentation to facilitate the commercialization of new products in the US and internationally. Maintain dashboard for regulatory approvals for international country license / registration renewals.
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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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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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Collaborate with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community. 6+ years' experience in Drug Safety and Pharmacovigilance in pharmaceutical or biotech company, CRO or regulatory agency within Drug Safety/Pharmacovigilance, with both investigational and marketed products.
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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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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.
$88,182.79 - $110,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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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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You will also demonstrate leadership and comprehensive understanding of global vaccines CMC regulations and guidelines by applying interpersonal skills and expert Regulatory Affairs Vaccines (RAV) CMC knowledge to identify, communicate, address, and overcome challenges that arise during development and commercialization.
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Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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The Flagship Communications and Public Affairs team is responsible for overseeing all aspects of communications, government and regulatory affairs, and social impact. Participate in weekly Communications & Public Affairs team meetings and collaborate with team members as needed to support both PBU work and corporate communications activity including events, government relations, digital, internal communications, and media relations.
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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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Work closely with individual clinical teams as well as functional area partners (e.g., Translational research, Precision Medicine and diagnostics, Regulatory Affairs, Market Access, Clinical Development) to identify and implement end-to-end Data Science solutions aimed at facilitating decision making.
$142,000 - $244,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Director supervises and evaluates the Faculty Services Office (FSO) promotions/appointments administrators, writer/editors, and a project analyst and serves as the department's primary administrative partner to the Harvard Medical School (HMS) Office of Faculty Affairs, Mass General Brigham Central Credentialing Office (including Enrollment), and the Mass General Brigham Office for Global Professionals and Scholars (PIPS.
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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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regulatory affairs jobs Title: sr regulatory affairs associate in Melrose, MA
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