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Lead in the preparation and submittal of regulatory applications and on‐going application maintenance in accordance with established timelines and submission dates in compliance with local and global regulatory requirements for the different application types (eg, IND, NDA/BLA, MAA, CTA DMF.
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You will be the RAM lead/subject expert in safety and regulatory compliance for Rail and Marine transport (hazmat/non-hazmat), coordinating with Global safety and regulatory management.
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The Senior Counsel will provide general legal support, including corporate/commercial, regulatory, and compliance support relating to the Company’s transactional, regulatory, compliance and other activities.
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Assessing regulatory requirements for regulatory capital and compliance issues in the banking industry (FRTB, CCAR, ICAAP, PRA, Volker, Basel III etc.) A career in Capital Management, within Financial Services Advisory Risk & Regulatory, will allow you to advise financial institutions on continuing to enhance their stress testing capabilities and responding to regulatory feedback.
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Develop and implement food safety, food defense, and quality systems to ensure compliance with federal, state, and local government regulatory food safety requirements and Safe Quality Foods Institute (SQFI) or British Retail Consortium (BRC) standards.
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They are accountable for execution of all applicable risk programs (Credit, Market, Financial Crimes, Operational, Regulatory Compliance), which includes effectively following and adhering to applicable Wells Fargo policies and procedures, appropriately fulfilling risk and compliance obligations, timely and effective escalation and remediation of issues, and making sound risk decisions.
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Liaise with existing fund clients to coordinate compliance related due diligence visits and provide ongoing Fund CCO support to clients of ALPS. Assist regulators and consultants by providing requested information necessary to conduct regulatory/compliance reviews and examinations of the funds assigned.
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Ensures compliance with regulatory commitments. This role will be responsible for implementing and managing the site Quality Systems, Training and Document Control programs, identifying, and assessing regulatory and quality risks during site GMP operations, and ensuring adherence to global regulations and BMS policies and procedures.
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We seek an experienced Interim Regulatory Compliance Counsel with a wide range of compliance experience to assist with GMP efforts, assure adherence to GxP guidelines and standards in laboratories and R&D facilities, manufacturing and distributing processes, lead internal investigations, spearhead remediation processes, and communicate with the appropriate regulators.
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And other applicable New Jersey regulatory agencies, including Waterfront Development, Coastal Zone Management, Coastal Area Facility Review Act (CAFRA), Natural Heritage Program (NHP), freshwater and coastal wetlands, watershed and land management (Land Resource Protection), stormwater management, New Jersey Pinelands Commission, former New Jersey Meadowlands Commission, New Jersey Flood Hazard Area Rules, marine sediment and dredging, and the Green Acres Program.
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Required Experience: Must have attained or worked towards obtaining the ICB Certified Regulatory Compliance Manager (CRCM) certification. Bachelors Degree and five plus years regulatory compliance related work experience.
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Adhere to applicable compliance/operational risk controls in accordance with Company or regulatory standards and policies. Assist and stay current with the Consumer and Business Banking AML (Anti-Money Laundering), BSA (Bank Secrecy Act) and KYC (Know Your Customer) processes and related activities.
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Demonstrates knowledge of complex processes related to clinical studies, regulatory issues, CRO operations, and compliance practices. Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to your supervisor.
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Knowledge of deviation, CAPA, Compliance, BPDR, Recall, Change Control, manufacturing processes, Packaging process, Regulatory inspection, technical writing. The Senior Compliance Specialist is responsible for maintaining the Morris Plains QMS and Inspection Management.
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Knowledge of deviation, CAPA, Compliant, BPDR, Recall, Change Control, manufacturing processes, Packaging process, Regulatory inspection, technical writing. APQR Governance- author and/or review the PQR/APQR data contributions aligned with compliance activities.
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regulatory compliance jobs in Florham Park, NJ
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