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Otsuka Pharmaceutical Development & Commercialization, Inc. is seeking a seasoned clinical development leader with substantial Bio/Pharma industry experience, coupled with a track record of leading a global team to develop and advance an innovative pipeline including accomplishing successful regulatory filings and approvals.
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The Scientist will provide subject-matter expertise in a range of translational research strategies, immunoassay techniques, assay development, and fit-for-purpose Regulatory approach. Experience and aptitude for development and implementation of translational or biomarker strategies, preparation of scientific publications, presentations, and regulatory documents is a plus.
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Previous experience with Regulatory affairs, IRB submissions, On-site visits, and/or Data Integrity. Collaborate with NIH clinical research scientists, Principal Investigators, Research Coordinators, Protocol Navigators, NINDS Sponsor representatives, CTU staff, and safety, regulatory, and monitoring entities.
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Job Details Protective Security Officer - Nuclear Regulatory Commission (NRC) May perform other related duties as assigned by a security Lieutenant and/or security Project Manager.
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Ensure insurance coverage is compliant with loan documents, servicing agreements, Fannie Mae, Freddie Mac, HUD, Capital Markets, regulations and reporting requirements; stay up to date on changes in regulatory and lender requirements.
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Oversee the flawless management of all financial systems and operations Manage all accounts, ledgers, and reporting systems, ensuring compliance with appropriate Generally Accepted Accounting Principles, IRS and regulatory requirements.
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Strong understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements and demonstrated experience integrating these disciplines in the context of drug development.
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Extensive working knowledge of international Cell Therapy GxP regulatory frameworks, regulations, and guidanceWhen we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines.
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Implementation of the regional strategy(s) in support of the project globallyLead regulatory interactions and the review processes for assigned asset strategyEnsuring appropriate interaction with global/regional counterparts and commercial teams where applicableEnsuring compliance with global/ regional requirements at all stages of product life cycle.
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Programmatic and fundraising colleagues who do not necessarily have finance backgrounds A track record in grants management Regulatory Knowledge: Familiarity with financial regulations, compliance, and reporting requirements is crucial.
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The incumbent is expected to adhere to all standard operating procedures and policies established for execution of Bioanalytical studies and sample testing projects under applicable regulatory compliance requirements.
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Ensure financial systems comply with regulatory requirements, industry standards, and best practices for data security and privacy. - Experience with financial regulatory compliance (e.g., Sarbanes-Oxley Act, General Data Protection Regulation (GDPR.
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Communicate effectively with business stakeholders, IT teams, and management to ensure alignment on system requirements and project status. - Excellent communication, problem-solving, and project management skills.
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And regulatory requirements and industry standards related to privileged access (e.g., GDPR, SOX, PCI-DSS). Current information security certification, such as Certified Information Systems Security Professional (CISSP) or Certified Information Security Manager (CISM.
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Provide scientific guidance and oversight while factoring in technical, regulatory, and intellectual property considerations and risk assessment. He/she will work closely with research, manufacturing, validation, quality and regulatory functions to support development of molecules leading to commercialization.
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regulatory job Title: regulatory project manager Company: Jobget in Rockville, MD
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