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Work in close collaboration on safety issues with the Director of Drug Safety and colleagues from Regulatory Affairs, Medical Affairs, Data Management, and Clinical Operations.
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Provide practical and timely legal guidance on issues related to clinical, biometric, medical affairs, patient advocacy, regulatory affairs, pharmacovigilance, program and asset management, commercial development, pricing & reimbursement, sales, marketing, market access, patient services, and government affairs.
$306,700 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Support development of strategies to improve effectiveness and efficiency of overall regulatory and scientific affairs environment. 5+ years of experience in the food and/or dietary supplements regulatory environment with full expertise on regulatory compliance (i.e. product composition; DSHEA; ingredient qualification, e.g., GRAS, NDI; labeling; Health Claims & Structure/Function Claims; overall product communications.
$150,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Rocket Pharma is seeking an accomplished and strategic Senior Director of Regulatory CMC to lead our Chemistry, Manufacturing, and Controls (CMC) regulatory affairs. The ideal candidate will possess extensive experience in CMC regulatory affairs, particularly in writing CMC sections for INDs, NDAs, BLAs, and MAAs, as well as strong leadership skills.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Role: Regulatory Affairs Specialist. Prepare reports responding to inquiries from ERCOT, other RTO/ISOs, and regulatory or government agencies. Follow developments before Public Utility Commission of Texas (PUCT), Texas legislative proceedings, and other regulatory or government agencies that affect gas and power marketing and trading activities and report on such developments to relevant groups within the company.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Level I: Bachelor's Degree (Life/Natural/Clinical Sciences/Regulatory Sciences or equivalent) plus 1 years of experience in clinical research and/or FDA Regulatory Affairs OR High School plus 5 years of experience in clinical research and/or FDA Regulatory Affairs OR equivalent combination of education and experience AND Obtain CRS certification within Two (2) years of hire.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Associate Director, CMC Regulatory Affairs. The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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Job : Govt, Corp, & Regulatory Affairs. Job Description - Mgr Revenue Requirements (Regulatory Accounting Manager) (254223) Analyze, interpret and communicate accounting and financial planning impacts due to regulatory commission rate case decisions and rulemakings regarding distribution, transmission, supply, and surcharge revenue, ratemaking, and cost recovery matters.
Full-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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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.
$329,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The selected candidate will also work collaboratively with Quality Assurance to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to author Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.
$155,000 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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The Senior Manager, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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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.
$286,700 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Partner with Drug Metabolism and Pharmacokinetic (DMPK) and Bioanalytical (BA) Subject Matter Experts (SMEs) to author, review and track regulatory documents. Understand the impact of DMPK/BA and interdependencies with other functional teams within the enterprise including Pharmacology, Toxicology, Clinical and Regulatory disciplines.
$59 an hourFull-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Job Description: POSITION Nonclinical Regulatory Document and Scientific Writer. " Experience reviewing regulatory documents, DMPK and BA reports, and non-GLP/GLP data and notebooks. Assist with quality review of DMPK reports that are generated by DMPK scientists by fully reviewing the raw data outputs/electronic notebooks and ensuring validity and quality of reported data in the reports, in addition to reviewing DMPK regulatory documents, editing of nonclinical study reports for regulatory acceptance and adherence to company templates, SOPs, DMPK/BA methods, work practices and FDA GLPs, as applicable.
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Serve as an expert reviewer of material prepared by other internal departments such as public affairs, regulatory affairs, legislative affairs, and state affairs. Identify, develop, and deliver tools to quickly assess and report trade and supply chain activities, policy and regulatory developments, and potential threats or opportunities for the industry.
$140,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago
regulatory affairs jobs Title: sr director Company: Merck
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