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Regulatory expertise in project leadership, preferably negotiation with and conduct of meetings with the FDA and successful preparation and submission of IND/CTA/MAA/NDA/BLA with explicit CMC focus for biologics and/or small molecule modalities.
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Our Chemical Substance Registration Team, part of Global Regulatory Affairs (GRA), is growing, and we are looking for a dedicated and passionate individual to join our team as a Senior Manager, to drive chemical control compliance programs for our DEB and Enzymes businesses.
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Job Description - Regulatory Affairs Manager (Energy - Mid-West) (241704013) Job Title: Regulatory Affairs Manager (Energy Industry) Regulatory Affairs Manager (Energy - Mid-West.
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Working within cross-company development project teams, the Regulatory Affairs Directorwill leverage his/her expertise to translate clinical, nonclinical, and CMC regulatory requirements into actionable strategic plans.
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You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
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Desired Skills and ExperienceCertified Anti-Money Laundering Specialist (CAMS) or Certified Fraud Examiner (CFE)Certified Internal Auditor (CIA), Certified Public Accountant (CPA), Certified Regulatory Compliance Manager (CRCM),Audit / Assurance or operational experience in large scale enterprise environment / financial institution.
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Familiarity with Applied Behavior Analysis and competency in the implementation of fundamental procedures as described in Epics training protocols and any regulatory or funder requirements (e.g., registered behavior technician training.
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Author and review SOPs relating to analytical development, quality control, and regulatory compliance. Responsible for ensuring analytical development and stability activities meet regulatory CMC and quality compliance guidelines for IND/NDA/IMPD/MAready submissions.
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This incumbent will have responsibility for OSHA and any other EHS related regulatory compliance, injury prevention programs, environmental compliance such as EMS (Environmental Management Systems) and any other environmental related regulatory compliance, injury case management (i.e. working knowledge of injury claims), site security, technical safety advice and have the ability to educate others on safety in a very diverse work environment.
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Monitor and maintain awareness of regulatory changes relative to the Fintech products and services and work; support the Chief Compliance Officer in efforts to achieve compliance with regulatory changes within Fintech.
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Assist Chief Fiduciary Officer and National Fiduciary Team Leader with national projects to meet risk and regulatory objectives. Support Chief Fiduciary Officer in managing internal audits, regulatory exams, compliance testing, and control testing.
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15 years of experience in drinking water treatment with at least 5 years in water quality and treatment (water quality analysis, treatment evaluations, process design, regulatory compliance assessments, distribution water quality analysis, etc.
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Aiding clients to comply with applicable regulatory policies, such as: FERC OATT, NERC TPL, TOP, PRC, and FAC standards, Generator Interconnection Applications, and associated studies. Sargent & Lundy delivers comprehensive project services-from consulting, design and implementation to construction management, commissioning and operations/maintenance-with an emphasis on quality and safety.
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Responsible for applying the provision of trusts consistent with the documents, applicable statutes and regulations as well as meeting KYC, AML, and other regulatory compliance standards. Responsible for applying the provision of trusts consistent with the documents, applicable statutes and regulations as well as meeting KYC, AML, and other regulatory compliance standards.
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Knowledge around new Fraud/AML scenarios, FinCEN guidance Industry guidance, regulatory requirements, and industry "best practices" for anti-money laundering and KYC programs is an asset. Participate in ongoing training to stay abreast of regulatory and industry changes.
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regulatory job Title: regulatory affairs project manager Company: Gpac in Claymont, DE
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