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Providing robust legal regulatory and healthcare compliance support to Medical Affairs teams responsible for Astellas Medical Specialties and Established Brands, including advising on Medical Affairs strategies and tactics (including core medical plans.
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You will lead a program focused on managing third party providers, import duty expense, customs classification, maintaining good standing and participation in programs with U.S. Customs and Border Protection, ensuring all U.S. and Canadian import compliance regulatory requirements are met and fostering a culture of integrity and ethical conduct throughout the organization.
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Facilitate and assist with safety, regulatory, quality, and industry audits relating to Airport Operations, including but not limited to FAA, CAAs, OSHA, IATA, and DoD. The Senior Investigator is responsible for supporting the day-to-day FAA, industry partner, and other regulatory activities including handling incident cases, responses, audits, surveillance activity, and investigations.
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This role will also involve supporting GLP, and Phase I/II GMP manufacture of their Nanoparticles and associated drug substances, so adherence to and understanding of our client's quality guidelines and regulatory guidance where required is critical.
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This position is ideal for self-starters with bank auditor experience, regulatory examiner experience or banking industry experience within risk management. Audit experience within Banking, Accounting / Consulting, Regulatory Agencies, or Financial InstitutionsCertified Internal Auditor (CIA) or willing to obtainAdditional Certifications:CRCM, CPA.
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This role will also involve supporting GLP, and Phase I/II GMP manufacture of Nanoparticles and associated drug substances, so adherence to and understanding of quality guidelines and regulatory guidance where required is critical.
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Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance.
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Partner across functions to ensure robust systems in place to meet regulatory and stakeholder expectations in the areas of environmental compliance, product compliance, supplier conduct, and sustainability/ESG; support response to internal and external stakeholder information requests in these areas.
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Collaborate effectively in a matrixed environment with Medical Affairs, Creative/CRM/Digital agencies, Media, Market Research, Analytics, Business Technology Solutions (BTS), Field Operations, and Medical/Regulatory/Compliance/Legal integrated business partners.
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This position is responsible for ensuring that raw and ready-to-eat (RTE) beef, veal, pork, poultry and seafood products and plant processes comply with corporate policies and regulatory standards across multiple production plants, supporting the company’s Food Safety and Quality culture, and leading continuous improvement initiatives.
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Lead engagement with applicable regulatory authorities and internal stakeholders when required; represent FBIN as subject matter leader with external stakeholders. Our portfolio of brands includes Moen, House of Rohl, Aqualisa, SpringWell, Therma-Tru, Larson, Fiberon, Master Lock, SentrySafe and Yale residential.
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Inform Bank management and lines of business regarding changes to Federal and State regulatory law. Attend applicable regulatory training, seminars and conferences to maintain regulatory consumer compliance knowledge.
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We currently have a great opportunity available for a Regulatory Affairs Manager. Minimum 5+ years of progressive experience in medical devices/IVD/biotech industry Regulatory Affairs required, including experience in Armed Forces.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). We offer a competitive total rewards package, including a stable base salary, to recognize associate achievements.
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Collaborate with Regulatory Affairs and Pharmacovigilance in the development of product labeling and periodic safety reports, as applicable. Purpose and Scope:The Medical Lead, Oncology, MUS (Medical Affairs-United States), is accountable for the development and execution of medical and scientific strategies for one or more products within the Therapeutic Area (TA.
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regulatory job Title: sr regulatory affairs associate in Northbrook, IL
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