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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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Advanced life science degree or certification in Regulatory Affairs Sciences preferred. 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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The Associate Director, Regulatory Affairs – Regulatory Project Management (RPM) provides planning and drives coordination of global and US regulatory activities. The Associate Director, RPM provides impactful contributions to the RPM group and the regulatory affairs organization by identifying gaps in RPM processes and suggesting and integrating operational and procedural excellence best practice into RPM processes to enhance regulatory affairs capabilities.
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CMC regulatory affairs, or a related field within the pharmaceutical or medical device industry. Specific certifications related to drug-device combination products or regulatory affairs (e.g., Regulatory Affairs Certification) could be advantageous.
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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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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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This position will work with the AVP of BOP and Umbrella to drive assigned product line initiatives across multiple departments including Underwriting, Regulatory, Marketing, Claims, Actuarial, IT, Government Affairs, and Legal.
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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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Johnson & Johnson MedTech is recruiting for a Regulatory Affairs Business Product Owner - MedTech , located in Raritan, NJ or Puerto Rico. Remote work is optional based on the candidate.
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He/she/they manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she/they defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global.
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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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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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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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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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regulatory affairs jobs Company: Mallinckrodt Pharmaceuticals in Bedminster, NJ
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