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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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JOB DESCRIPTION Job TitleSr. Regulatory Affairs Specialist-CT/AMIJob DescriptionThe Senior RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory roadmaps—understanding competitive claim landscape, legislative initiatives, and marketing strategy.
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May develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director.
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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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Minimum of 10 years of experience working in the pharmaceutical/biotechnology industry with direct experience in CMC Regulatory Affairs; Regulatory Affairs Certification (RAC) a plus.
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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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Regulatory Affairs Manager III. At least 3-5 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field.
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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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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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Experience in providing regulatory CMC strategy for submission of clinical trial application (IMPD/IND) and marketing authorization application (NDA/MAA) for small molecule development compounds, including chemical drug, peptide and oligonucleotide.
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Participate in CMC project team meetings and provide Regulatory CMC support as needed, including update to the teams on follow-up actions, information request, risk assessment and mitigation in support of clinical trial application and marketing application.
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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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Develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. They are seeking a Regulatory CMC Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product.
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Partner with Corporate Communications, Advocacy and Government Affairs strategy as it pertains to the global market access environments. Lead Medical Affairs/HEOR on overall Product Value demonstration strategies and evidence generation focused on payers.
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At least 3-5 years of relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity including at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field.
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regulatory affairs manager jobs Title: north america in Woburn, MA
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