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Experience and solid knowledge of Pharmacovigilance specificallyProficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDxExperienced in understanding and interpreting regulatory guidelines and documents.
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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
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Serves as AMC Liaison with executive leadership interfacing with continuum of care providers and public agencies including: SNF Administrators, vendors, CHHAs, LDSS-APS/CPS, NYS-OMH, OPWDD, MHLS among other regulatory agencies.
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Serve as a QA representation at key governance meetings whereby GCLP/GLP activities are being discussed (Regulatory affairs, Research unit LT, GRDC etc.,) Effectively interacts with broad range of colleagues in order to establish a globally aligned GCLP/GLP strategy across DS teams.
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In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
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Actively collaborate with multiple internal stakeholders (Technical Services, Marketing Managers, Commercial Team, Communications, Business Analytics, Market Research, Regulatory, Legal, Finance, Pricing, Learning & Development, Manufacturing, etc.
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Ensures efficient, timely GMP, HSE and regulatory compliant maintenance and calibration of systems and equipment to include troubleshooting instrument failures with the ability to diagnose and perform effective repair.
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Prepare/review technical documents including development/tech transfer reports and CMC regulatory submissions - Participate on cross-functional teams to progress both early and late stage drug candidates.
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Participates in regulatory and legislative affairs for assigned states, including serving on boards and bureaus. The Regional Vice President leads the execution of the CORE (middle market and small commercial) businesses operating plans, new business development, retention, and distribution management.
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The Senior Risk analyst supports Bank responses to audit, model risk management and regulatory examinations and for all Credit Risk Stress Testing Activities and coordinates these activities with the Senior Director - Risk Analytics, the as well as the heads of Model Development, Model Implementation, and Capital Planning.
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This role will be responsible for implementing and managing the site Quality Systems, Training and Document Control programs, identifying, and assessing regulatory and quality risks during site GMP operations, and ensuring adherence to global regulations and BMS policies and procedures.
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Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO’s, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
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You will be the RAM lead/subject expert in safety and regulatory compliance for Rail and Marine transport (hazmat/non-hazmat), coordinating with Global safety and regulatory management. Manage Regulatory, Safety, and Security compliance for Rail and Marine transportation and associated Roehm equipment fleets.
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Act in compliance with Heritage Healthcare's regulatory and professional standards and guidelines. Speech Language Pathologist - PRN. Hold a current Certificate of Clinical Competence in Speech- Language Pathology (CCC-SLP) credential offered by the American Speech-Language-Hearing Association.
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And other applicable New Jersey regulatory agencies, including Waterfront Development, Coastal Zone Management, Coastal Area Facility Review Act (CAFRA), Natural Heritage Program (NHP), freshwater and coastal wetlands, watershed and land management (Land Resource Protection), stormwater management, New Jersey Pinelands Commission, former New Jersey Meadowlands Commission, New Jersey Flood Hazard Area Rules, marine sediment and dredging, and the Green Acres Program.
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regulatory job in Morris Plains, NJ
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