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You will provide global product stewardship and regulatory affairs services for a line of chemical products that support Videojet printers. Manage our SDS, label, and regulatory affairs systems.
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You will guide the business with respect to quality and regulatory affairs issues, complaint handling and initiatives to maximize the operational capacity of Oticon Medical's distribution of auditory implantable devices.
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Piper Companies is currently looking for an experienced Sr. Regulatory Specialist (IND Submissions) in Philadelphia, Pennsylvania (PA) to work for an innovative and growing biologic oncology pharmaceutical company.
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In the position of Regulatory Program Director in Roche / Genentech Pharma Technical Regulatory (PTR), you will be accountable for Health Authority interactions pertaining to CMC Information (i.e.: CMC information in an IND, IMPD and NDA/BLA/MAA filings), as well as informational and pre-submission meetings with global Health Authorities, partners and industry experts.
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You will support Cash's vision by working together with other compliance and counsel, Data Science, and Operations teams to support the management of CCO related inquiries arising during audits, regulatory examinations, and other ad-hoc independent requests.
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Site Regulatory Specialist page is loaded. Site Regulatory Specialist. a document management system for regulatory paper and electronic files for each study at the site. organization of Regulatory File room, including archiving notebooks as needed.
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Dorsey and Whitney LLP is seeking a Regulatory Affairs Associate with four to six years of experience to join the Anchorage office. Regulatory Affairs Associate (#856) Among Dorsey's many distinguished alumni are U.S. Supreme Court Justice Harry Blackmun, noted law professor and scholar William Prosser, Minnesota's first woman judge Betty Washburn, former U.S. Vice President and Ambassador to Japan Walter Mondale, U.S. Senator Amy Klobuchar, former Corporation Counsel of the City of New York Zachary Carter, and U.S. Secretary of Agriculture Tom Vilsack.
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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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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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This position will oversee all aspects of submission and continuous reporting to the relevant regulatory agencies, including the Institutional Review Board, the Food and Drug Administration (FDA), the Institutional Biosafety Committee, the institutional Radiation Safety Committee and the pharmaceutical sponsor, funding foundation or governmental agency.
$5,700 - $6,800 a monthFull-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Accountable for the management and delivery of all CMC regulatory milestones, including global investigational drug filings (e.g., IND / CTA / IMPD / GMO), registrational filings (e.g., BLA, NDS, MAA, and supplements), and responses to health authority questions/requests.
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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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Full span of experience must include: Statistical and financial modeling including Allowance for Credit Loss (ACL); Data analysis using SAS and Python; Risk management, including identification and mitigation of risks, and adherence to regulatory requirements; Processing large datasets using Python and SAS; and Conducting sensitivity tests and model stress testing.
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First line operations manager of all activities at MercyOne Des Moines and a member of the pharmacy leadership team.
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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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