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Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD, or MD preferred) Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred) Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA) A broad knowledge of development and life-cycle management is preferred.
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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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Radiopharmaceutical Management: Oversee the preparation and distribution of FDG and NaF, ensuring adherence to SOPs and regulatory standards. This role demands meticulous attention to detail and a steadfast commitment to regulatory compliance, contributing to the pharmacies reputation for excellence in patient care.
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Plans, coordinates, and reviews US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (e.g. Protocol Amendments, Form 1572s, Information Amendments, Meeting Requests/Background Materials, DSUR, IND/NDA/BLA annual reports, BTD request etc.
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Description SummaryThe Treasury Manager is responsible for cash management, cash flow forecasting, preparing, and executing monthly quarterly and daily intercompany funds flow schedule, foreign exchange management, monthly and quarterly reporting requirements for Treasurer, accounting, and external reporting and ad-hoc project work to support on-going business objectives and assist with debt compliance and capital allocation strategy.
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The CMC Regulatory Technical Writer II authors high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers, change controls and technical reports. The technical writer contributes to various US, EU and rest of world (ROW) dossiers such as NDA, MAA, IND, IMPD, CTA, amendments, supplements, variations and other communications with regulatory authorities (e.g., briefing documents for meetings.
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This role requires a strong leader with a deep understanding of commercial patient services, pharmacovigilance, quality assurance, and regulatory compliance. As a Quality and Compliance Team Lead, you will serve as a liaison to key clients, where your leadership and expertise will contribute to the continuous improvement of our drug safety processes, regulatory and contract compliance, and overall patient safety.
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Knowledge of integration requirements, security protocols, data privacy, and regulatory compliance about enterprise architecture, D365, and Microsoft Power Platform. Collaborate with security and compliance teams to ensure adherence to data privacy, security standards, and regulatory requirements.
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CMC regulatory affairs, or a related field within the pharmaceutical or medical device industry. Fulfill the independent Reviewer responsibility of Design History File Documents to ensure they are organized, complete, thorough and compliant with regulatory and Amneal requirements completeness and be primary signatory on said documents.
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Proficiency 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/CDx.
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Issue designs and support them through the project lifecycle including: design, drawing reviews, electromagnetic emissions analysis, and regulatory submissions (FCC and EME). Interface with project managers, real estate, construction, field operations, engineering, sales, marketing, finance and regulatory to ensure that our network quality and financial objectives are met.
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Including at least 3 years of relevant Regulatory Affairs experience, or Advanced degree (PharmD, PhD, MD or DVM) with at least 2 years of regulatory or relevant pharmaceutical/biotechnology industry experience required.
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Collaborate as appropriate with Everest’s Chief Compliance Officer in monitoring and updating compliance policies and procedures governing disclosure requirements worldwide; assist with the design of related compliance training; develop strategies for efficient, effective compliance with legislative and regulatory requirements; and participate in internal investigations as needed.
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Advise on the regulatory issues related to interest rate risk, capital management and liquidity management. Provide research on new regulations and their impact on the Bank. Partner with Businesses in the development of new products and advise on the regulatory implications.
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Ensuring regulatory/trade compliance, risk mitigation of supply chain disruptions and adherence to safety regulations and SOPs (including IATA, IMDG, Import/Export trade compliance and local regulatory requirements based upon chemicals in inventory.
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regulatory job Company: Mallinckrodt Pharmaceuticals in Bridgewater, NJ
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