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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
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As an integral member of Pharmacy Services, the IDS/Pharmacy Regulatory Coordinator's role also includes assuring accurate record keeping, filling, compounding and delivering of investigational drug products to study coordinators, study nurses and patients.
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Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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Providing comprehensive and high-quality legal support in the areas of sales, marketing, promotional/medical/patient materials, patient access/support/reimbursement, government contracts and pricing, managed care, fraud & abuse, and regulatory and legal compliance with federal and state statutes, FCPA, rules and regulations, privacy, safety/product liability law, and other laws, regulations and Company policies and procedures.
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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. 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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The incumbent is responsible for analyzing PGW regulatory compliance in communications and actions from regulators and ensuring operating practices are in accordance with local, Commonwealth and federal regulations and requirements.
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Enrollment, Informed Consent, patient, oncology, patient consenting, clinical research coordinator, clinical trial, gcp, edc, Chart review, Emr, Patient recruitment, Clinical research, oncology, Pre-screening patients, Medical record, Data entry, Regulatory.
$28 - $33 an hourFull-timeRemoteExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Familiarity with Artificial Intelligence/ Machine Learning, Robotics Process Automation and Blockchain and their impact on the regulatory environment. We work with complex multinational companies to understand the regulatory landscape and influence business decisions.
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The Sarbanes-Oxley (SOX) Control and Compliance Manager will lead the Company’s internal controls program, perform regulatory compliance audits as needed, and support the Company’s Environmental, Social and Governance (ESG) and Enterprise Risk Management (ERM) programs.
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Assist the regulatory specialist in preparing for all local and Central Institutional Review Board (IRB) documentation through the IRB, including submissions, continuing reviews, amendments, modifications, and adverse event reporting and all regulatory documentation with pharmaceutical companies and clinical research organizations (CROs.
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2 Years experience in pharmaceutical development and/or manufacturing with CMC regulatory experience or related (e.g. CMC writer, lab experience). The Associate/Manager - CMC Regulatory is responsible for the preparation and delivery of high-quality CMC regulatory submissions.
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The Regulatory Law Unit's Airport Division is seeking a licensed Pennsylvania Attorney to fill an Assistant City Solicitor or Deputy City Solicitor position. The attorney will work on a wide range of transactional and compliance matters handled by the Airports Division, including negotiating and drafting of contracts and advising the airport staff on legal and regulatory matters, as necessary, for the City to operate and develop its two airports.
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Maintain a centralized policy and procedure inventory program that aligns with regulatory and policy requirements, supported by a centralized governance process to monitor and enforce standards.
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Audit operational areas and delegated vendors for compliance and ensure Jefferson Health Plans (JHP) is meeting applicable federal and state laws and regulations, and contractual requirements as set forth by all regulatory entities including but not limited to Pennsylvania State regulatory agencies (DHS, DOH and PID) and Centers for Medicare and Medicaid (CMS.
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Understanding of Environmental, Social, and Governance (ESG) standards and Enterprise Risk Management (ERM) programs is a plus. Certified Public Accountant (CPA) or Certified Internal Auditor (CIA) preferred.
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regulatory job in Philadelphia, PA
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