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Represent PCDS at team meetings and coordinate between PCDS and other functions including CMC, Regulatory Affairs, Clinical Operations, and Platform and Discovery Sciences. The candidate should possess an in-depth understanding of safety pharmacology, investigative and regulatory toxicology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
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Assessing regulatory requirements for regulatory capital and compliance issues in the banking industry (FRTB, CCAR, ICAAP, PRA, Volker, Basel III etc.) A career in Capital Management, within Financial Services Advisory Risk & Regulatory, will allow you to advise financial institutions on continuing to enhance their stress testing capabilities and responding to regulatory feedback.
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The Associate Director ensures compliance with all regulatory policies and guidelines including federal, state, local, as well as the policies and procedures outlined by DFCI and the Dana-Farber Harvard Cancer Center (DF/HCC) consortium.
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In this role, you will report to the Deputy General Counsel and work closely with the growing Fintech and HTS legal team, product leads, and other senior business partners to provide advice on complex regulatory matters impacting Hopper’s global business, and drive and execute bespoke and creative commercial contracts with Hopper’s HTS partners (including banks, consumer brands, airlines, hotels, and online travel agents) around the world.
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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). Bachelor s degree (or foreign education equivalent) in Applied Computer Science, Computer Science, Engineering, Information Technology, Information Systems, Information Management, Business Administration, or a closely related field and six (6) years of experience as a Director, Full Stack Engineering (or closely related occupation) designing and developing scalable, high performance, secure Web applications using secure protocols and SAFe agile framework.
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Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression. Deep understanding of regulatory requirements and quality standards in pharmaceutical manufacturing.
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Certified Anti-Money Laundering Specialist (CAMS), Certified Internal Auditor (CIA), Certified Public Accountant (CPA), Certified Regulatory Compliance Manager (CRCM), or Certified Fraud Examiner (CFE.
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5+ years working in the pharmaceutical industry, and strong experience writing CMC regulatory sections (including IND’s/ CTA’s) Author and manage process for CMC regulatory documents including module 3 CMC submissions, technical reports and SOPs.
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals. Join Takeda as a Senior Director, GRA 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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Deliver enterprise projects and regulatory legislative initiatives, provide patches with current software version, and perform server installation, configuration, performance tuning and production support.
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Investor Services compromises of Compliance Services (investor AML/KYC, sanctions screening and related regulatory services) and Investor Relations. Keep abreast of industry and regulatory changes, identify impact to and opportunities for Investor Services.
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Author and oversee DMPK/clinical pharmacology related sections of health authority communication documents including regulatory meeting briefing documents, IB, pediatric investigational plans (PIP) and popPK modeling/simulation reports.
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Knowledge of Massachusetts regulatory standards is required with preferred experience in regulatory compliance with standards from Department of Public Health (DPH), Department of Early Education and Care (DEEC), Department of Developmental Disabilities (DDS), Department of Children and Families (DCF), and Department of Elementary and Secondary Education (DESE.
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Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.
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Ensures compliance with XBRL reporting with industry-standard and regulatory-compliant tagging. Reporting to the Executive Director of Finance & Controller assist with SEC Reporting and drafting of 10-Q, 10-K, and 8-K, S-8 and other filings as required.
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regulatory job Title: director Company: Govhr Usa in Waltham, MA
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