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CMC Regulatory Affairs Manager (Remote) CMC Regulatory Affairs. Regulatory Affairs Manager. This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.
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Reporting to the Senior Vice President, Global Regulatory Affairs, this key senior leadership role serves as a recognized regulatory policy leader and influential spokesperson in support of Amgen’s global regulatory initiatives.
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B.S. in biochemistry, chemistry, biology, or a related protein or synthetic biotechnology sciences field or an equivalent level of biopharmaceutical experience with responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
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The Head of Regulatory Affairs Policy & Intelligence leads a team of remote professionals located in both the United States and Europe who are responsible for harnessing their diverse, broad, and industry-leading expertise to influence regulators on important issues in drug development and regulation that benefit Amgens business and the patients we serve.
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Plans, implements and trains site personnel on various EHS/Regulatory policies and programs, including, but not limited to safety practices, fire prevention, hazard communication, personal protective equipment, regulations and standards, and incident investigation.
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Liaise between support organizations, Microbiology, Quality, Engineering, Validation, Regulatory Affairs, Process Development, etc. Kelly® Science & Clinical is seeking a Contract Sr. Validation Engineer at a cutting-edge Therapeutics Company client in the Los Angeles Area. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
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The Senior Regulatory Compliance Analyst, working under general supervision, performs assessment and auditing functions in accordance with the Company's Mortgage Compliance Program to ensure Pennymac is complying with various mortgage-related federal and state regulations.
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Mizuho Americas LLC is seeking curious minds to join our data warehouse sourcing and analytics team in the role of Sr. Business and Data Analyst to collaborate with various IT and business stakeholders, including but not limited to Risk, Finance, Regulatory Reporting.
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As a Sr. Engineering Manager, you will lead a group of talented engineers in the design of high-performance test solutions for Skyworks innovative analog, RF, and mixed signal products. Background in RF design software such as Keysight Advanced Design System (ADS) and/or Ansys HFSS.
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Familiar with pharmaceutical sciences, quality, compliance and regulatory GMP requirements, associated with biologics and synthetic chemical manufacturing and QC testing. In this team-based role you will directly add to the success of the Product Quality team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Regulatory, Quality Engineering, International Quality and Process development on projects, issue resolution and investigations.
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In this vital VP role, you will lead the late clinical development strategy, planning and decision making for the Rare Disease therapeutic area (TA) as well as collaborate closely with counterpart leaders in Research, Early Development, Medical Affairs and Commercial functions to advance the Rare Disease pipeline and champion and contribute to business development opportunities in the Rare Disease area.
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Capsida Biotherapeutics is searching for a Sr. Associate II, Software Development Engineer to join our team and grow our computational capabilities in support of the experimental pipeline.
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Follow protocols and procedures, maintain accurate records in an electronic lab notebook, and generate quality data for use in drug development and regulatory filings. Process Development Sr Scientist- Mass Spectrometry page is loaded.
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The Computational Biology group in the Clinical Biomarkers & Diagnostics (CBD) department at Company is seeking a highly motivated Sr data scientist to join our team and contribute to develop machine learning modeling and prediction pipelines using multi-modal biomarker data from clinical trials.
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Requirements: PharmD, PhD, MD, or DO with one or more years of experience in clinical research, patient care, Medical/Scientific Affairs, and/or basic research. Requirements: PharmD, PhD, MD, or DO with one or more years of experience in clinical research, patient care, Medical/Scientific Affairs, and/or basic research.
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regulatory affairs jobs Title: sr regulatory affairs associate in Thousand Oaks, CA
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