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Work closely with NGS production, Quality and PreClinical Genotox for compliant execution of genotoxicity data packages in support of regulatory filings and clinical programs. Interact with Health Authorities, in writing and verbally, including pre-submission (e.g., pre-IND), scientific advice filings, IND or CTA, meeting briefing books, or other requests from global regulatory authorities.
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Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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We are seeking a Senior Manager in Regulatory CMC who can lead and contribute to CMC regulatory activities in support of Deciphera studies across all stages of clinical drug development.
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Scope of ResponsibilityWill serve as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical and/or CGT R&D, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives.
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Serve as the subject matter expert on Veeva Vault and related clinical trial management systems (CTMS), electronic trial master file (eTMF), and regulatory document management systems. Expertise in Veeva Vault or similar clinical trial management systems (CTMS), electronic trial master file (eTMF), or regulatory document management systems.
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A career in Treasury Advisory, within Risk & Regulatory Advisory, will allow you to advise financial institutions on developing strategies to optimize financial performance and risk management across financial risks, including liquidity risk, market risk, counterparty credit risk and interest rate risk.
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Knowledge of CFTC & NFA swap regulations is preferred to enhance the compliance program and assist the swap dealer and the Swap Dealer Chief Compliance Officers (CCO) to satisfy their regulatory obligations.
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Job Description PharmaLex is one of the largest worldwide providers of consulting services in the following focus areas: Quality Management & Compliance; Development Consulting & Scientific Affairs; Regulatory Affairs; and Pharmacovigilance, Epidemiology and Risk Management.
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Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs. Guides and ensures that the clinical study documentation (documents, images and other digital content) is correctly filed and archived, and that the study is maintained in a trial master file (TMF), so that documentation of GCP compliance is available, if required by a regulatory agency.
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Regulatory Affairs Manager *PC Regulatory Affairs - Waltham MAAt Miltenyi Biotec, 3, employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies.
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The candidate who assumes this role will lead a team of compliance professionals supporting execution of the Bank compliance management program, including risk assessments, compliance policies and procedures, training, issues management, complaint administration, regulatory filings, third party risk management and the Community Reinvestment Act (CRA.
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Provider Regulatory and Commercial Provide counsel to CCA regarding the following issues: Accountable for understanding federal and state health care law requirements applicable to CCA, including Medicare and Medicaid rules, HIPAA privacy and security, healthcare reform, legal and regulatory topics relating to CCA's status as a government contractor and integrated health care services delivery organization, fraud and abuse, Anti-Kickback, and Stark/self-referral requirements.
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The Director II Compliance will support the leadership team and own compliance across a number of disciplines, including but not limited to: Foreign Corrupt Practices Act, Anti Bribery/Anti-Corruption, HIPAA Compliance; Local and Federal Regulatory Compliance; Commercial and Specialty, Medicaid and Medicare Compliance; Finance; Procurement; Corporate Governance; and Human Resources.
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Basic understanding of learn FDA regulatory requirements and good clinical practice (GCP) As the Senior Manager/Associate Director ofRegulatory Strategy, you will play a critical role in driving the developmentand execution of regulatory strategies for our rare disease therapeuticprograms.
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Support project team lead to author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filing documents.
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hitrust regulatory jobs in Boston, MA
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