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Providing overall leadership and direction to the Quality Assurance and Regulatory Affairs McKesson 3PL Team. The Senior Director, QARA is principally responsible for the development and implementation of the Companys quality assurance program through the development and implementation of quality assurance and compliance standards via policies and procedures, training, auditing and monitoring, facilitating internal reporting, compliance-related investigations, and keeping Third Party Logistics VP of Quality Assurance & Regulatory Affairs informed on quality assurance and regulatory affairs matters.
$142,200 - $237,000 a yearExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Senior Regulatory Affairs Specialist - Electrophysiology page is loaded Senior Regulatory Affairs Specialist - Electrophysiology Apply locations United States - Minnesota - Plymouth United States - Minnesota - St. Paul time type Full time posted on Posted 3 Days Ago job requisition id 31080311 Abbott is a global healthcare leader that helps people live more fully at all stages of life.
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Senior Director, Global Regulatory Affairs Development Pipeline, Cell Therapy. Define and oversee oversight plans for vendors active in regulatory affairs on behalf of BioNTech.
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We are seeking a highly motivated Regulatory Affairs and Quality Assurance (RA/ QA) experienced professional to join DermBiont. Knowledge of GLP and GCP, Pharmacovigilance (PV), ICH, FDA requirements and guidelines for small molecules, including drafting, interpreting, and implementing quality assurance policies and procedures for regulatory documents, as well as establishing document management activities.
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This position reports to the Senior Director, Rates and Regulatory Strategy and is responsible all regulatory affairs and rates for Liberty’s gas and water utilities in New York. The Director will lead a team of regulatory professionals and be responsible for effective engagement with state regulators and key stakeholders to advance Liberty's interests and initiatives, the preparation of rate cases and compliance filings, and development of regulatory strategy.
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This position reports to the VP, Global Regulatory Affairs. Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package.
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PhD in biomedical sciences or related fields, with a degree or certification in regulatory disciplines or Regulatory Affairs Certification (RAC) as a plus. Expertise in regulatory submission structure and content, including IND, CTA, MAA, NDA, BLA, and extensive knowledge of regulatory guidelines of FDA, ICH, EMA, EU NCAs, MHRA, and other international regulatory agencies.
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Regulatory Affairs Specialist IV. Minimum of 8 years experience in Regulatory Affairs, or equivalent combination of education and experience relating to IVD/Medical Devices/Biologics.
$107,200 - $147,400 a yearFull-timeExpandUpdated 3 months ago - UpvoteDownvoteShare Job
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Lead and mentor a team of regulatory affairs professionals, fostering their growth and development. cresilon.com The Director of Regulatory Affairs (RA) is a functional leader of Cresilon.
$160,000 - $220,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Role: Regulatory Affairs Associate. Role: Regulatory Affairs Associate. Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports.
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The Senior Regulatory Affairs Specialist will provide regulatory support on a range of Endoscopy devices and activities which include new product introduction, evaluation of post market design changes, international submission support, commercial, manufacturing, & compliance support as well as other responsibilities aligned with global medical device regulations and goals of the business.
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Regulatory Affairs Certification (R.A.C) Serve as internal expert and manage global regulatory activities associated with review, approval and lifecycle management of promotional materials for client’s marketed and development products including (but not limited to) medical devices, combination products, software as a medical device (SaMD), and pharmaceutical packaging.
$101,000 - $140,000 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products. Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, (the globe minus US, EU, Canada.
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Reports and is directly responsible to the Vice President of Scientific Affairs. Directs and oversees all activities that implement policies related to regulatory matters applicable to the compounding of drug products.
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The Manager Regulatory Affairs & Quality Americas have responsibility for setting priorities and expectations among their direct reports and monitoring/reporting on budget, planning and logistics.
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Title: regulatory affairs
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