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In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
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Oversee study start up activities of CROs (e.g. Site identification, Feasibility, Site selection, Contract negotiation and Clinical Study Agreement finalization, Translations, EC and Regulatory submission, Site initiation etc.
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Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations.
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Knowledge of Bank Secrecy Act regulatory requirements, including CTRs and SARs, and basic knowledge of banking regulations. BSA Analyst responsibilities include: Administering the Bank Secrecy Act/Anti-Money Laundering Program and related procedures in accordance with Bank’s policies, procedures, and applicable federal regulations.
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Assist QRM team members with the creation and maintenance of a regulatory framework for Quality Risk Management (QRM) related activities, including review or creation of Controlled Documents (e.g. SOPs, Work Instructions) and/or tools, and templates.
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Firm Type: Law Firm, Experience: 2 Years, CFIUS and International Trade/Export Controls Associate AttorneyJob Overview: A law firm in Princeton, NJ is seeking a skilled Associate Attorney with 2-4 years of experience in international trade regulatory, compliance, and enforcement matters.
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Ensure the local HSE management system is effectively designed, implemented, and controlled and meets Firmenich standards, ISO standards, and all relevant regulatory requirements. Thorough knowledge of OSHA regulations and experience working with regulatory agencies.
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Assists the College President and Vice President of Institutional Effectiveness in developing and interpreting data relating to student services and academic affairs to ensure programs correlate with the college community’s needs.
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Identify develop operational institutional pathways to grow scientific engagements research and data for the enterprise with a special focus on community oncology centers and accounts for ongoing working groups and consortium support Contributes to the scientific affairs HCE partnership execution with select external research partners to maximize effective and compliant delivery of research with external organizations.
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Advise on a broad range of complex and strategic legal and business matters, including intellectual property (copyright, trademarks, patents, trade secrets), international distribution, commercial transactions, government contracts, tax matters, mergers and acquisitions, marketing, export control and compliance, data protection, privacy, matters applicable to the testing industry (administration, scoring and reporting scores), and other applicable regulatory matters.
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Author, and approve protocol and reports in accordance with internal and external regulatory expectations (APS, Engineering, Tech Transfer). Author, and approve protocol and reports in accordance with internal and external regulatory expectations (APS, Engineering, Tech Transfer.
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EisnerAmper is seeking a Consulting Internal Audit Manager to join our Risk & Compliance Services practice, focusing on Internal Audit, Internal Controls, and Regulatory Compliance. EisnerAmper is seeking a Consulting Internal Audit Manager to join our Risk & Compliance Services practice, focusing on Internal Audit, Internal Controls, and Regulatory Compliance.
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Knowledge of key concepts including unit operations, processes, quality by design (QbD), tech transfer, process validation, quality attributes, and regulatory milestones across pharma development.
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Successful candidate will have a strong understanding of the drug development process from preclinical pharmacology through to regulatory approval and the principles, concepts, practices, and standards of pharmaceutical program management.
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Broad functional experience encompassing business performance, commercial analysis, strategy, finance, regulatory compliance, procurement and IT. Recruit, develop, and bring to life a high performing cross-functional team that maximizes self/team across all elements of the value chain: Operations, Finance, Sales, Field and Trade Marketing, Key Account Development and In Store Execution Specialists.
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regulatory affairs jobs Title: sr affairs associate Company: Thermo Fisher Scientific in Lawrence, NJ
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