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Basic Qualifications:Bachelor's DegreeExperience of all phases of the drug development process in Regulatory Affairs preferredKnowledge of clinical trial and licensing requirements in all major countries (EU,US, JP, China) and ideally knowledge of other key Agency processes globally.
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Develop constellation modeling and analyses for LEO/MEO/GEO satellite systems and conduct analyses against regulatory masks. This is an exciting position where the candidate will be involved in design and testing of state-of-the-art RF and phased-array antenna systems for next generation LEO/MEO/GEO satellite communication systems.
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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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Ensure compliance with all regulatory requirements, including SEC filings, Sarbanes-Oxley (SOX) compliance, and tax obligations. You will work closely with executive leadership and key stakeholders to drive financial performance, optimize capital structure, and ensure compliance with regulatory requirements.
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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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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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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). Issuing Authority, Series 07 - FINRA, Series 63 - FINRA, Series 65 - FINRA, Series 66 - FINRACompany Overview Fidelity Investments is a privately held company with a mission to strengthen the financial well-being of our clients.
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Certification demonstrates knowledge and skills of sterile processing practices in accordance with regulatory guidelines such as Food and Drug Administration (FDA) and the Joint Commission (JC.
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Thorough understanding of the cross functional drug development processes (Clinical Operations, Biometrics, and Regulatory Affairs) and context applicable to safety surveillance activities required.
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Deep understanding of the US regulatory environment, the Food, Drug and Cosmetic Act and latest regulations and guidance's with sound knowledge of intelligence tools and methods; preference will be given to candidates with experience supporting vaccines and infectious disease products, and experience across a number of disciplines including Pharmacovigilance, Quality, and Clinical Development.
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Analyze DOE requirements involving Memorandums of Agreement (MOAs), Memorandums of Understanding (MOUs) as they may relate to DOE lessees, contractors, and other federal agency activities such as the Nuclear Regulatory Commission related to the ACP Facilities.
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Develop and enforce IT policies and standards to safeguard data integrity, security, and regulatory compliance. Develop, own, maintain, and execute the CaIvert Impact / Climate United IT Strategy Plan to support organizational objectives and regulatory compliance.
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Strong operational, compliance and regulatory understanding, including deep HUD Project Based Section 8 programs and Low-Income Housing Tax Credit (LIHTC) familiarity and knowledge. Prepare reports of all operational financial data to the Regional Property Manager, Property Staff Accounts and other Corporate Departments as requested.
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Experience implementing controls for various cybersecurity & regulatory frameworks such as NIST, PCI, SOX, or HIPAA. Develop and maintain security policies, procedures, and standards to ensure compliance with industry best practices and regulatory requirements.
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Under the direction of the Project Finance Manager and alongside the home office project team, the Project Finance Analyst 3 supports the management of the financial and contractual elements of United State Agency for International Development (USAID)-funded projects in collaboration with other departments/functional support areas including Accounting, Contracts and Procurement, Human Resources, and corporate/division finance.
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regulatory job Title: regulatory affairs project manager Company: Jobget in Rockville, MD
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