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As Principal Regulatory Affairs Specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies.
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Collaborate across the organization in Regulatory Affairs, Clinical Operations, and Patient Engagement. Clinical research neurologist, investigator, neurologist, principal investigator, PI, neurology, part-time, clinical trials, clinical drug development, oversight, leadership, FDA, GCP, safety, assessment, regulations, medical license, clinical research, on-site, Raleigh, RTP, NC, North Carolina.
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Our client is seeking a Principal Regulatory Affairs Specialist for their Pleasanton, CA location. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment.
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Your teamAs a Principal Engineer at Baxter, you will provide Sterility Assurance leadership and technical support to multi-disciplinary product development teams, domestic/international manufacturing facilities, Regulatory Affairs and internal Sterility Assurance customers.
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As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting regulatory submissions in the US, EU and outside of US (OUS) geographies.
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This role will develop strong relationships, collaborate, and interact with various departments (i.e., Quality Operations, Quality Systems, Chemistry Manufacturing, and Controls (CMC), Analytical, Regulatory Affairs, Pharmacovigilance, Procurement), and all levels of management at Akebia to accomplish company objectives.
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Principal Regulatory Affairs Specialist. Job Segment: Regulatory Affairs, Compliance, Pharmaceutical, Product Development, Technical Writer, Legal, Science, Research, Technology.
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Coordinate and direct the activities of as many as (20) internal departments including regulatory affairs, general counsel and customer & community affairs and as many as (15) external government and private agencies including Public Utility Commissions and other utilities in the process of delivering assigned projects.
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Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society). Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
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Collaborate with regulatory affairs specialists to address any queries or modifications requested by the IRB.Work closely with multidisciplinary teams to conceptualize and design research studies, ensuring alignment with ethical and regulatory guidelines.
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Minimum of 10 years’ experience in Regulatory Affairs or Strategy or similar field required, including experience with Marketing Applications (FDA and/or EMA) and FDA REMS. Expert knowledge of scientific principles and concepts.
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The Principal Scientist will work closely with individuals from Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA endpoint strategies are consistent with and executed and interpreted to support the product strategy.
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The individual will co-lead or guide teams on the development, validation, analysis and interpretation of COA endpoints to support regulatory submissions, reimbursement evidence dossiers, payer interactions, and publications.
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Job DescriptionUnder the general direction of the Patient-Centered Endpoints & Strategy (PaCES) group lead, the Principal Scientist has responsibility for supporting or co-leading global Clinical Outcomes Assessment (COA) endpoint strategies, including Patient-Reported Outcomes for specific disease areas.
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We are seeking a highly experienced Senior Principal Statistical Programmer with a strong background in Medical Affairs and Oncology/Hematology Therapeutic Area. ClinChoice is searching for a Senior Principal Programmer Consultant to join one of our clients in their Medical Affairs Team.
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regulatory affairs jobs Title: principal
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