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The Regulatory Affairs Specialist is expected to facilitate the development and submission of FDA IND applications and annual reports, and development/maintenance of study specific case report forms and source document tools, as well as, to provide direct regulatory/compliance guidance and facilitate investigator initiated trials and investigator-initiated multi-site trials.
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Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents.
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Serve as the subject matter expert on cross-functional teams to lead projects, direct GLP bioanalytical validations and sample analysis across all nonclinical, DMPK and clinical pharmacology development.
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Keeps abreast of and ensures compliance with regulatory practices (e.g. FDA, EMA, and ICH guidance and recommendations) and industry data standards (e.g. CDISC). The Head of Biopharma Biostatistics serves as a leader within the global biostatistics department responsible for strategic and operational oversight of the biostatistics and statistical programming activities for Emmes' biopharma portfolio in key therapeutic areas such as vaccine and infectious diseases, ophthalmology, CNS, rare disease and cell and gene therapy among others.
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With oversight from the Executive Steward, manage Stewarding Operations as required for the efficient operation of the department, including Health, Safety, FDA, and OSHA regulations. Manage all aspects of the Stewarding operations under the guidance of the Executive Steward.
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Represent regulatory affairs on cross-functional project teams, providing CMC regulatory guidance to ensure the company remains in compliance with applicable and phase-appropriate regulatory standards, guidelines, and best practices.
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Conducts performance evaluations; provides guidance and has primary responsibility for performance expectations, staff competencies, and meeting State and Federal Regulatory agency requirements (FDA, NRC, DOH, JC, ACR, ASTRO.
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As a Senior Regulatory Counsel, you will be responsible for providing day-to-day guidance on legal issues and risk mitigation strategies for RCP related to the regulation of our consumer products, as to (i) content and use and (ii) packaging, online and other claims.
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Extensive knowledge of the following areas:US customs regulations preferably with products under FDA authorityProduct HTS and ECCN classifications, valuation, and Country of Origin determinations for pharmaceutical productsOther Export Licensing regulations and processes - for example, EU, UK, & CHAutomated Commercial Environment (ACE) and Import Trade Auxiliary Communications System (ITACS)Government regulationsRegulatory & Compliance functions.
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Collaborate regularly with the Office of Ethics and Compliance, Medical Affairs, and Regulatory Affairs departments concerning a broad range of legal, regulatory and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, industry codes such as AdvaMed and PhRMA, the Sunshine Act, Foreign Corrupt Practices Act, and competition law in connection with product labeling, promotional, and non-promotional activities.
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Serves as the Serialization Site Lead by providing serialization training and strategy; including providing industry insights and knowledge on DSCSrelated progress; and guidance on GS1 US and HDA serialization data and label standards as well as FDA requirements.
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In-depth knowledge and experience with GLP and/or GCP regulations and industry standards (EPA, OECD, FDA, EU guidance) Provide guidance and technical support to laboratory staff on GLP regulations.
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Actively engages with industry related agencies and professional membership organizations including CMS, FDA, UNOS, AOPO, AATB, EBAA, ASHI, CLIA, and ISODP. Provides interpretation and guidance of regulations and standards for consideration in the formulation of business strategies related to organ, tissue, ocular, HLA and Clinical Laboratory operations and organizational regulatory compliance.
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Performs various educational duties under supervision and guidance from Director Sterile Processing. HSPA, CBSPD, AORN, The Joint Commission, FDA, CDC, DNV OSHA, AAMI and those of VMFH.
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The Product Development (PD) Senior Scientist I, under minimal guidance, designs, plans and conducts pre-formulation, formulation and process development activities as well as scale-up trials of complex projects using risk-based approach.
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