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Minimum of 5 years of experience as a Developer/Business Systems Analyst with a focus on QMS in the medical device industry, including expertise in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
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A scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD.
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Degree RequirementsMinimum BA/BS DegreeExperience RequirementsMinimum of 10+ years Pharmaceutical industry experience – prefer knowledge of biotechnology / cell therapy products, including multi-disciplined experience, 8+ years CMC regulatory strategy (biologics/cell therapy experience preferred.
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The US GRPA team is responsible for monitoring new developments impacting the US prudential regulatory capital regime, as administered by the US Agencies - the Federal Reserve, OCC, and FDIC. Strong technical working knowledge of the prudential regulatory capital rules relating to the calculation of regulatory capital resources, RWAs, and the leverage ratio, with an emphasis on Market Risk RWAs and Market Risk Covered Positions.
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Do you have 3+ years of experience in regulatory affairs, and do you have experience in labeling / preparing safety data sheets? Required Knowledge: Regulatory, Scientific / Technical, QA, Business acumen.
$90,000 - $110,000ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Capability in managing deliverables essential for regulatory permit applications, CEQA documents, and environmental due diligence investigations (e.g., wetland delineations, rare plant surveys, habitat assessments, biological resources technical reports.
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The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.
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Utility-scale renewable energy regulatory affairs and market policy experience working with IPPs / Developers / Owners. Renewables Regulatory Policy Leader - Acts as a Regulatory Subject Matter Expert (SME) to the Project development, EPC, transmission market analytics teams for ERCOT / PUCT filings and other state filling protocols in the Southwest Regions.
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Risk | Trading Risk Management (TRM) | Regulatory Risk Manager | Location. Risk, Regulatory Risk Manager, NYC. Immediately escalate to senior management in case issues with any regulatory deliverables.
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You will need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide Precision Medicine global regulatory guidance.
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Possess working knowledge of relevant Federal, State, and local regulatory requirements (e.g., ESA, NEPA, CWA, MBTA, BGEPA); We provide environmental permitting, regulatory compliance, air quality, remediation, weed management, stormwater management, and other environmental services to clients throughout the country.
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He/she manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or contract manufacturing organizations (CMOs), or alliance partners.
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The Director, Regulatory Oversight position reports to the Associate Provost Research Integrity and Compliance (AP- RIC ) and is responsible for leading the administrative, regulatory, and programmatic activities supporting the university’s Human Research Protection Program ( HRPP ), animal care and use program, and oversight committees for the use of recombinant.
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Executive Office support: serves as Chief of Staff to the VP, Head of Alexion Regulatory Affairs, supporting internal and external engagement and managing activities as part of the function’s Executive Office.
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Requirements Gathering and Analytics:Partner with onshore teams and stakeholders to gather business requirements related to QMS functionalities, with a focus on Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
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regulatory job Title: sr regulatory affairs associate Company: Kelly Services
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