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At minimum 10 years’ experience in the pharmaceutical industry in Biologics/Research & Development/Regulatory Affairs. Ensure strategic regional regulatory input which is in consideration of the commercial strategy and is provided into global regulatory teams and that the Regional Regulatory TA Team supports the Global Regulatory Affairs (GRA) vision of excellence, good scientific practice, integrity and compliance with regulatory standards.
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As a Barclays US Basel IV Regulatory Capital Reporting Assistant Vice President (AVP), you will be working in the Regulatory Capital Team and will be tasked with the development and on-going circulation and reporting of both point in time and Comprehensive Capital Analysis and Review (CCAR) Projected risk weighted assets (RWAs), capital leverage, and Single Counterparty Credit Limits (SCCL) Large Exposures for Barclays IHC (Intermediate Holding Company) to internal and external stakeholders.
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Serve as a key subject matter resource on healthcare laws and regulations, including, without limitation, monitoring of regulatory developments, and legal research on regulatory issues, including fraud and abuse issues, HIPAA compliance, EMTALA, Medicare and Medicaid compliance, licensure issues, pay-to-play issues, corporate governance and regulatory issues related to tax-exempt entities.
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Experience with the contents and implementation of specific regulatory initiatives such as: Dodd-Frank, general consumer compliance, regulatory structure and organizations including FRB, OCC and CFTC.
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We have an exciting opportunity for a Regulatory Compliance Manager – Renewable Natural Gas (RNG), who will be responsible for developing, maintaining, and enforcing company compliance policies and procedures related to RNG operations.
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You will need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide Precision Medicine global regulatory guidance.
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Reporting to the Specialty Group Compliance Manager, the Regulatory Compliance Analyst will be responsible for accurately performing core regulatory compliance processes, including but not limited to data calls and regulatory reporting, documentation of complaints, legal mail, regulator inquiries, economic sanctions, Medicare reporting, mail distribution and telephone inquiries.
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Leads or participates in strategic project initiatives to within Shared Services/D&A (SSDA) to mitigate risk, enhance controls or remediate audit, loan review or regulatory findings. Leads or participates in strategic project initiatives to within Regional Commercial to mitigate risk, enhance controls or remediate audit, loan review or regulatory findings.
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Proclinical is seeking an Associate Director, US Regulatory Affairs, Advertising & Promotion for a large global pharmaceutical company with locations in New Jersey and Massachusetts. As the PRC Regulatory Affairs representative, you will work with brand on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations, company policies, and applicable Industry Guidelines for the advertising and promotion of prescription drugs, biologics, and devices.
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Work with Regulatory Operations to ensure assigned projects are submitted on-time following the eCTD requirements related to labeling. Proficient knowledge of SPL development and FDA drug listing requirementsPC, Microsoft Office Suite with a proficiency in Microsoft Word and Microsoft Excel Adobe Acrobat Professional Familiarity with TVT and Intagras SPL portal preferredFunctionRegulatory AffairsSub FunctionMedical Regulatory AffairsReports ToIn process of validationAlready Working @TEVA.
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Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields. Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
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Experience in providing regulatory strategic input into the Oncology drug development preferred. 7 or More Years of relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs.
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Under the direction of Regulatory Affairs management, participate in drug development from early stage development through final formulation, ensuring compliance with principles of Quality-by-Design, cGMP, and FDA rules and regulations.
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Experience in pharmaceutical marketing and new product launch coordination
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The Pharmaceutical Regulatory Affairs Senior Manager will use their experience and knowledge in pharmaceutical industry regulatory affairs to lead and manage complex projects for our clients in the pharmaceutical sector, and provide strategic advice, guidance, and solutions on regulatory matters.
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Title: regulatory Company: Clarivate Plc in Florham Park, NJ
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