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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated organizational leadership skills at both functional and enterprise levels.
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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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This fellowship is intended to provide experience for Doctors of Pharmacy within the pharmaceutical industry with a focus on Regulatory Affairs for prescription drugs and devices at Novo Nordisk Inc. The fellow will gain the skills needed to pursue a career within the pharmaceutical industry where their education and experience can make a significant contribution to satisfying business needs and achieving company goals.
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Our work depends on Regulatory Affairs Manager joining our team to contribute to PKI and Identity Management policy development, technical liaison and advisor. Seize your opportunity to make a personal impact as a Regulatory Affairs Manager supporting a PKI Government High Value Asset Mission Essential Function program.
$155,934 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Our client is looking to fill the role of CMC Regulatory Affairs Manager. Provide CMC regulatory strategy for investigational, new and marketing products (biologics and small molecule focus.
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The Executive Director, Regulatory Affairs will develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local regulations.
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The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing strategic direction, operational support, and technical expertise for. Initiates process improvements and contributes to global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix teams.
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Advanced life science degree or certification in Regulatory Affairs Sciences preferred. Experience and solid knowledge of Pharmacovigilance specificallyProficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDxExperienced in understanding and interpreting regulatory guidelines and documents.
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Work closely with Global Patient Safety and Risk Management (GPSRM), Clinical Research, Regulatory Affairs, Clinical Operations, Biostatistics, and Medical Affairs to inform clinical development and real-world outcomes and answer product- and disease-area research questions for Alnylam RNAi therapeutics using observational studies, EMR/claims data, and RWE. The Senior Director, Epidemiology reports directly to the Senior Vice President, Data Science, Statistics, and Epidemiology.
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Knowledge of HUD programs, regulatory compliance, the affordable housing industry, the Austin/Travis County Homelessness Response System, and the Homeless Management Information System (HMIS). The qualified candidate will coordinate service through the Veterans Affairs Supportive Housing (HUD-VASH) program and other rental assistance programs.
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This position will work closely with the Technical Operations (CMC) functional groups and Regulatory Affairs department to plan and author high quality regulatory submissions to health authorities and will have frequent interaction with internal senior management, corporate partners, international regulators and external experts.
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KNOWLEDGE, SKILLS, and ABILITIES Bachelors in any of the following degrees from an accredited university/college: Regulatory Science, Regulatory Compliance, Regulatory Affairs, Environmental Science, biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology, medicine, and engineering.
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Cross-functional collaboration/interaction with Clinical Affairs, R&D, Regulatory, Quality, OEC, Legal, Global Marketing & Commercial teams. Supporting the Director of Global Scientific Affairs, in conjunction with the Sr. Manager and Project Manager in Global Scientific Affairs, with KOL management as it relates to investigator-sponsored studies (ISS) and/or collaborative research studies (CRS.
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The position is responsible for leading CMC regulatory activities within the Regulatory Affairs department, to support all ORIC’s clinical development programs of oncology products.
$235,000 a yearFull-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Washington DC, Department of Consumer and Regulatory Affairs, Board of Industrial Trades, Class 1 – Steam Engineer License MD, Class 1 – Steam Engineer License. Ten (10) years’ experience as a mechanical engineer or journeyman mechanic with field experience in either maritime or industrial plant (construction, operation, or maintenance) as well as one of the following licenses: National Institute for the Uniform Licensing of Power Engineers, Inc. (NIULPE) First Class Power Engineer License.
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regulatory affairs jobs Title: regulatory affairs specialist Company: Stryker Corporation
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