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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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SummaryThe Regulatory Affairs Specialist will reside within strategic business unit, Huber Specialty Minerals (HSM), at Huber Engineered Materials (HEM). U.S. Market-Based Salary Range Regulatory Affairs Specialist [$81,700.00 - $108,100.00] In addition to base compensation, individuals may be eligible for an annual discretionary bonus and profit-sharing payout.
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Preferred Masters degree in student affairs, college student counseling, higher education administration, social work, program evaluation. Regularly collaborates with internal partners such as the Dean's Office, Offices of Academic and Faculty Affairs, Community Engagement, Medical Education, Equity, Inclusion, and Diversity, Information and Technology, Facilities, Procurement, Human Resources, Sim Center and Marketing and Communications to coordinate, implement, and evaluate student centered co and extracurricular programming.
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We want people to join our team in the role of External Affairs Coordinator with expertise in community outreach, marketing, and public relations. DCI Donor Services operates three organ procurement/tissue recovery organizations: New Mexico Donor Services, Sierra Donor Services, and Tennessee Donor Services.
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Working under the Director of the RNA Program and closely with the CEO, you will collaborate with cross-functional teams, including research, manufacturing, product development, clinical development, and regulatory affairs to ensure successful RNA vaccine development.
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Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.
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A minimum of 6-10 years experience in product stewardship, regulatory affairs, compliance, chemical consultancy, and/or risk assessment. The ideal candidate will have experience in chemical and environmental regulatory compliance, packaging regulations, product stewardship and industrial risk management in the medical device or manufacturing industries.
$175,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Inside this Business GroupIntel’s Legal, Trade, and Government Affairs (LTG) group offers unique opportunities to work in a variety of areas, including counsel to Intel businesses; technology and intellectual property licensing; patent prosecution; trademarks and brands; litigation, mergers, acquisitions and investing; public policy, legislative and regulatory lobbying; global trade, export, import, and customs; and corporate compliance.
$284,620 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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A successful candidate will be highly regarded by both the Business and TGS leadership, skilled at navigating and driving large matrix teams, and successful at delivering technology solutions for PLM, PDM, Complaints Mgmt, Regulatory Management, Medical Affairs clinical trials and claims management.
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15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
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Regulatory Affairs: Prepare and review regulatory submissions related to DMPK, including INDs and NDAs. Interact with regulatory agencies as needed to address DMPK-related inquiries and ensure compliance.
$265,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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Work with Government Affairs to develop positions with respect to key legislative and regulatory developments. Reporting to the Chief Privacy and Innovation Governance Officer, the Chief Privacy Counsel will lead the Privacy Legal team; counsel on high-profile issues related to privacy, cybersecurity, data use, and technology matters; and partner closely with IT, Cigna Information Protection, Data Governance, Digital & Analytics, Government Affairs, and Enterprise Risk Management.
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The Regulatory Affairs Business Risk Officer is a first line professional within the Wholesale Banking division managing and assisting the business with regulatory adherence with a strong focus on BSA/AML, change management and people manager of a first line KYC team.
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We seek outstanding candidates with teaching experience in the following: industry experience in entrepreneurship, drug/ medical device development, data science, regulatory affairs, clinical and medical affairs, quality management, project management, finance, business operations, research and development, biometrics, health economics and outcomes research or manufacturing.
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regulatory affairs jobs Title: affairs specialist Company: Beigene
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