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Collaborate with cross-functional teams (process R&D, analytical development, supply chain, quality, clinical, regulatory, DMPK, and tox) to meet CMC and program goals. Extensive experience in late-phase drug product development and commercial development with CMC regulatory filings for the US (NDA), Europe (MAA), Japan, and China.
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This person will provide medical/scientific expert advice and guidance to key customers for ADC products & relevant therapeutic areas, including scientific exchange & professional development with key thought leaders/external experts and provides medical/scientific affairs support to the US commercial team.
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Work collaboratively with Manufacturing, QA and Regulatory to support CMC analytical deliverables. Author and revise SOPs, deviations, CRs and LIRs. Areas of responsibility include but are not limited to testing samples for Appearance, pH, UV and water content, HPLC, ELISA, western blot and SDS-PAGE as needed.
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Knowledge of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and regulatory pharmaceutical marketing and manufacturing principles, practices, and their application.
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Serve as a point of contact within the medical and scientific affairs team for thought leaders and external experts within an assigned geographic area in order to satisfy their needs for scientific knowledge in a therapeutic area and, when requested, relevant ADC products, to support their safe, effective and appropriate use.
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If selected, you will become an integral member of the Privacy Legal Team. As part of Disney’s world-class Legal & Global Affairs Department, the Privacy Legal Team is made up of subject-matter experts who are responsible for providing comprehensive support in the areas of data privacy, information security, and data governance to Disney’s diverse businesses around the globe.
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Federal regulations require the use of GLP for conducting studies that support or are intended to support applications for research or marketing permits for pesticide products regulated by the EPA. These regulations require implementation of a robust quality management system to ensure the validity, integrity and reliability of data submitted for regulatory evaluation and EPA approval.
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7-10+ years Pharmaceutical industry experience, including multi-disciplined experience, 6+ years CMC regulatory strategy. Knowledge of CMC regulatory requirements during development and post-approval and experience with global CMC regulations for small molecule products.
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Hands-on experience with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fisher and HPLC (SEC, IEX, HIC, RP, affinity). What Revance invests in you: Competitive Compensation including base salary and annual target bonusFlexible unlimited PTO, summer & winter shutdowns, and 12 weeks parental leaveGenerous healthcare benefits (Company pays up to 90% of premiums for medical benefits), Employer HSA contribution, 401k match, tuition reimbursement, wellness discounts and much more Note: Revance has agreed to merge with Crown Laboratories.
$162,046 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Ability to proactively anticipate and resolve regulatory questions, to meet expected timelines for regulatory requirements. Thermo Fisher Scientific’s Clinical Diagnostics Fremont location is seeking an EHS Specialist II who will be responsible for supporting the Environmental Health and Safety initiatives for the site.
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Job Description: Job Responsibilities (listed in order of importance and/or time spent)Competent in the clinical management of home infusion patients including Patient management skills, the Nursing Process, the rules of Federal, state, and local regulatory entities that oversee and control the provision of care in a Home Health Agency.
$51.98 - $86.63Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Represents school in meetings with parents, regulatory officials, and the general public Education & Experience: A four-year College Degree from a fully accredited institution preferably in Education, Child Psychology, Math, Science, English, History, or Social Science is required.
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La Terra Fina (LTF) is seeking an Inventory Control Specialist (Swing Shift) (2:00 pm - 10:30 pm) to execute all coordination of system inventory transactions and movements, daily warehouse transfers and inventory adjustments, specializing in the resolution of any inventory related problems.
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This position serves as primary support to clinical and operational leadership in monitoring and evaluating processes for outcomes management, performance improvement, patient safety and regulatory compliance.
$82.94 - $109.47 an hourFull-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Desired candidate will be responsible for the review and assurance of complete and complaint response as well as the on-time submission to all regulatory investigations and requests for information from regulators across the globe including but not limited to NHTSA (US), DPAC (China), TC (Canada), RDW (Netherlands), KBA (Germany), DVSA (United Kingdom), VSCC (Taiwan), and MLIT (Japan.
$258,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday
regulatory affairs jobs Title: regulatory affairs specialist Company: Beigene in Fremont, CA
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