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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
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ERM delivers a wide range of climate change services including decarbonization strategy development, creation of Scope 1, 2, and 3 carbon inventories, Task Force on Climate-related Financial Disclosure (TCFD) analysis and reporting, strategy development, policy and regulatory analysis, target setting, and benchmarking.
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Experience with Agile framework, DevSecOps processes, knowledge of cloud security, GxP, GDPR and other relevant regulatory compliance. Certifications such as Microsoft Certified: Azure Developer Associate, Certified Software Development Professional (CSDP), Certified Secure Software Lifecycle Professional, or similar is preferred.
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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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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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Familiarity with genomics assay qualification/validation guidelines and guidance (FDA, CAP, CLIA, ACMG, NYSDOH, global regulatory requirements for assay development). Knowledge of clinical sample analysis regulatory and quality frameworks and guidance in the lab and at vendors (such as GCP, CLIA, CAP, and NYDOH.
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Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management and regulatory issues. Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management and regulatory issues.
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Author, and approve protocol and reports in accordance with internal and external regulatory expectations (APS, Engineering, Tech Transfer). Manufacturing Science & Technology Specialist SRG offers flexible staffing solutions with a national presence.
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Works collaboratively with OPDC Vendors as well as the GPQ Department and other functional areas across Otsuka Affiliates and Subsidiaries to ensure compliance with local and global requirements and regulatory requirements.
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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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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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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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Author, and approve protocol and reports in accordance with internal and external regulatory expectations (Client, Engineering, Tech Transfer). Author, and approve protocol and reports in accordance with internal and external regulatory expectations (Client, Engineering, Tech Transfer.
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Performs tech transfer facility fitness, gap analysis, and risk assessment when on-boarding new programs. Familiarity with cell therapy processes and cGMP is strongly preferred. Must Have Gene/Cell Therapy Manufacturing experience⢠Minimum 3 years relevant experience in GMP biologic/cell therapy manufacturing technical or process support.
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The Associate Director, Regulatory Operations role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations.
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regulatory job Title: sr associate in Lawrence, NJ
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