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Responsible for approval of medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs for assigned therapeutic areas. Board Certified in therapeutic area and US fellowship training, or MD with 2-4 years’ experience in within the pharmaceutical industry including 2 years in-house Medical Affairs role, or PhD or PharmD with 5 years’ experience within the pharmaceutical industry, including experience in the therapeutic area and 3 years in an in-house Medical Affairs role; MD preferred.
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.
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Gather information/intelligence from all available sources in order to determine whether sufficient suspicion of money laundering, financing of terrorism or other criminal activities exists, to justify making a report to the relevant Regulatory Authority for the purpose of complying with legislative/regulatory requirements, and mitigating risk to RBC in line with established organizational policy.
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The Associate Director will work collaboratively across offices within the university – most directly with the Division of University Relations and also with Student Affairs, Academic Affairs, Development and Alumni Engagement, and other teams whose work impacts enrollment and student success.
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Essential Job Functions:Provides strategic advice on complex reporting and technological issues raised by the MRTS business units, Regulatory Services Management (“RSM”) team, Regulatory Operations teams, and other FINRA customers, as applicable.
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Perform other duties as assigned by the Academic Dean or Vice President of Academic Affairs. Associate Director, Supply Chain and Logistics, Center for Workforce Innovation. Some of the available technologies include Makerspace facilities for podcasting, 3D printing, crafts, and more, a combination of PC and Macintosh computers, scanners, printers, virtual reality headsets, learning hubs, and prayer and meditation rooms.
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Primary source verification: NJ Division of Consumer Affairs, Board of Nursing; University Hospital's designated Background Check Company. The Radiology RN (Nurse) is a Critical Care RN and delivers general nursing care to patients in all areas of the Radiology/Imaging and Pain Management Departments including: Vascular and Neurovascular Angiography, Pain Management and Diagnostic Imaging areas of Ultrasound, Computed Tomography (CT), Magnetic Resonance (MRI), X-ray, Nuclear Medicine and Mammography.
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Represents Jet Aviation as one company internally and externally with industry groups, regulatory bodies and the General Dynamics network. Represents Jet Aviation as one company internally and externally with industry groups, regulatory bodies and the General Dynamics network.
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Student Affairs offices include Undergraduate Student Life, Graduate Student Life, Community Standards and Title IX, Athletics, Residential and Dining Services, Residential Education, Office of Student Culture and Belonging, Student Health Services, Counseling and Psychological Services (CAPS), Disability Services, the Stevens Career Center, Stevens Technical Enrichment Program (STEP), Student Support, and University Events.
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Credential required: Current licensure as a Registered Nurse from the NJ State Board of Nursing, American Heart Association ACLS, PALS, BLSPrimary source verification: NJ Division of Consumer Affairs, Board of Nursing; University Hospital's designated Background Check CompanyPHYSICAL DEMANDS: Must possess good manual dexterity and good hearing acuity.
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You will report to the Executive Director and Head, CMC Regulatory Affairs. As part of the Regulatory Affairs CMC team, Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development ,commercialization and post approval LCM stages.
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This responsibility includes the development of security and safety policies and procedures, regulatory and legislative compliance, corporate aviation, guard management, alarm response, crisis management, ATM, branch and corporate building security and customer safety, physical crime investigations, workplace violence, fire and life safety, pre-employment screening, fraud and employee investigations.
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Interacts extensively with regional and corporate departments to provide medical/drug safety strategic input to clinical research (scientific and operational), regulatory affairs, and global quality/manufacturing.
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Externally, sustainability financial and performance data at the Mars Inc. level, inclusive of MW content, will be required to meet extensive regulatory reporting requirements and for voluntary disclosures in multiple major markets– with a particular focus on climate.
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Based out of Newark, NJ area, The Travel Clinical Research Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
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regulatory affairs jobs Title: sr regulatory affairs associate Company: General Electric in Nutley, NJ
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