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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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Dragonfly Therapeutics is seeking a Senior Director, reporting directly to the Senior Vice President, Head of Regulatory Affairs, to join the regulatory team within our Regulatory Affairs organization.
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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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The director will partner broadly with campus constituents such as but not limited to Development/Alumni Relations, LGBTQIA+ Center for Faculty & Staff, Residence Life/Housing, Student Activities, Howard Thurman Center for Common Ground, Student Health Services, Community & Inclusion, Government/Community Affairs, the Newbury Center, International Students and Scholars Office, and Athletics.
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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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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 6 days ago - UpvoteDownvoteShare Job
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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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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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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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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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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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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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And respond to regulatory inquiries related to DMPK, PK/PD, and clinical pharmacology. Determine scope, design, and planning and analysis of pharmacokinetic (PK) and pharmacodynamic (PD) studies, and modeling/simulations required from a drug development and regulatory perspective to take a project from concept to NDA submission.
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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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regulatory affairs jobs Title: sr regulatory affairs in Watertown, MA
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