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Leads nonclinical submission working groups to liaise effectively with cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory, Regulatory Operations, Drug Discovery Units, DMPK&M, and Drug Safety Research and Evaluation) to recognize aims, align on strategy, define executable timelines, and agree upon content for nonclinical regulatory submissions.
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Join Takeda as a Senior Director, GRA - CMC 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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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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CIB Trading Model Validation Associate Boston, United States of America The Associate, Risk Modeling is responsible for executing model risk management activities consistent with the enterprise model risk management framework, industry best-practice and regulatory guidance.
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Understanding of regulatory requirements and frameworks such as HIPAA, PCI-DSS, and NIST. Ensure CyberArk implementations comply with internal security policies, standards, and regulatory requirements.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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Ph. D. in scientific field (e.g., pharmacokinetics, pharmacology, toxicology), with minimum of 10 years of leadership experience with nonclinical regulatory writing within a pharmaceutical company or Contract Research Organization (CRO.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). Full stack software engineering combination among - Python, R, SQL, Java, JavaScript, HTML/CSS, C.
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The Senior Director monitors and supports teams responsible for study start-up activities, site activation and maintenance, compliance with all regulatory requirements and Federal guidance, subject accrual and management in close coordination with physician investigators, nursing, finance, and regulatory operations.
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Oversee and manage all financial and regulatory matters related to the health center’s 340B and Retail Pharmacy. The CFO will be leveraging their expertise in accounting, finance, and strategic planning, and will ensure fiscal responsibility, regulatory compliance, and alignment with organizational goals.
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In-depth knowledge of value-based care models, healthcare reimbursement methodologies, and regulatory requirements (e.g., MACRA, MIPS, ACOs). Monitor and analyze actuarial data to ensure alignment with population health objectives and regulatory requirements.
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Preferred knowledge in thermal analysis, X-ray powder diffraction, contributions to synthetic chemistry, and regulatory documentation. Proficient in organic chemistry tools (HPLC, LCMS, GC, NMR) and software (ChemDraw, Excel.
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Liaise directly with internal customers (Biometrics, Clinical Operations, Safety/Pharmacovigilance, Regulatory Affairs, etc.) Experience in supporting study-level audits and regulatory inspections.
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This role will involve extensive cross-functional collaboration with teams including Medical Affairs, Regulatory Affairs, Legal, Sales, Market Access, and Insights & Analytics. Cross-functional collaboration with Medical Affairs, Legal, Regulatory, Patient Services, Market Access, Data & Analytics, Market Insights, Competitive Intelligence, and US Commercial Field teams to support promotional activities.
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Manage all aspects of research compliance for the university: analyze and interpret policies and procedures relevant to research administration and expertise, ensuring compliance with regulatory policies governing research involving human subjects and conflicts of interest; including overseeing Simmons University’s Institutional Review Board (IRB.
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regulatory job Title: assistant Company: Citi in Watertown, MA
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