- Merck & Co. (Rahway, NJ)
- …degree with 12+ years of industry experience, including regulatory and/or compliance area and experience with process management in a regulated ... functional areas.Drive accountability for processes execution throughout GRACS through change management .-Develop, implement and report process objectives and… more
- Fidelity TalentSource LLC (Boston, MA)
- …You DeliverMaintain best in class compliance program through continuous assessment of regulatory change , impact to Asset Management business, and process ... Management will be responsible for supporting several critical regulatory filings, providing regulatory compliance ...preferred; 5+ years of compliance , legal, and/or regulatory experience in investment management or 2+… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- … compliance , regulatory and legal obligations. In this role on the Regulatory Compliance Team, you will support regulatory oversight of FDAS, ... maintenance of licensesSupervision of all tasks associated with licensing in compliance with statutory, regulatory , and NMLS requirements and… more
- Piedmont Airlines, Inc (Middletown, PA)
- …internal policies. This role involves monitoring and assessing the effectiveness of compliance controls, preparing detailed reports, and advising management on ... Compliance Accountant will work closely with external auditors, regulatory bodies, and cross-functional teams to ensure the organization's financial practices… more
- Amerant Bank (Miramar, FL)
- … program (ie, Enterprise Compliance Risk Assessment, Fair and Responsible Banking, change management and Compliance Quality Assurance) carried out by ... This role will manage regulatory compliance audits performed by in...specifically focusing on supporting audits over the Bank's regulations, compliance risk management and integrated audits of… more
- Amerant Bank (Coral Gables, FL)
- …new or modified products or services.Build and manage change management programs, including product/system changes and regulatory changes.Oversee and/or ... Requirements:5 or more years of experience in an equivalent role with residential compliance experience, in regulatory compliance at a bank, mortgage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.Summary Accountable for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ... and current regulatory requirements tracking all the complaints, deviations and change control related with the product and creating a trend evaluation scenario… more
- BioAgilytix (Durham, NC)
- …responsible for assisting in providing quality oversight of equipment management , reviewing mapping qualification reports and reviewing calibration certificates. He ... Computer System Validation Status listing and the Master Equipment listing Assist during regulatory agency and sponsor inspections Review and approve site change … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and Compliance GxP processes including audits, regulatory intelligence, regulatory inspections, change management , and quality risk management ... Develop and implement IS governance policies and procedures to ensure effective IS management and compliance . Change Management : Establish and manage… more
- Insmed Incorporated (San Diego, CA)
- …budget for drug product shipments.Own and support stability and sample management -related Deviations, CAPAs, and Change Controls. Drive related ... related topics.Establish and publish Key Performance Indicators (KPI) to track cGMP compliance for stability studies and sample management . Capture metric… more
- Fidelity TalentSource LLC (Boston, MA)
- …Product Group to create alignment and coordination with FDAM product development priorities. Regulatory Compliance and Risk Management : Ensuring compliance ... asset trading platforms and protocols, focusing on scalability, security, and regulatory compliance . Spearheading the design and development of innovative… more
- Pacer Staffing (Phoenix, AZ)
- …able to work closely with management and legal counsel to address regulatory compliance and liability issues. Competencies: Bias for Action and Achieving ... lead. Challenges: Within the role of Site EHS Manager change management will be a major focus...with management and legal counsel to address regulatory compliance and liability issues. Experience: A… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... Validation Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents ... ensuring that outsourced obligations are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate systems, processes… more
- American Honda Motor Co Inc (Marysville, OH)
- …to Bring the Future!About this Position: Support department and plant environmental regulatory compliance (CAA, CWA, RCRA, EPCRA, SWPPP, SPCC) and sustainability ... management systems to efficiently track and manage environmental compliance /performance.Coordinate assigned contractor SOW(s) (Scope of Work) (eg waste … more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …to the next level of care; Responsible for length of stay management , regulatory compliance , and attending/participating with interdisciplinary team ... outcomes.Maintains positive attitude, and communicates appropriately with patients/families, Physician, management and other staff; responds positively to change … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... in a manner that facilitates Health Authority reviews.- Supports company`s GMP Change Management Program. Evaluates CMC changes for portfolio biologics and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …knowledge in maintenance/metrology management , broad understanding of facilities management , cGMP compliance , EHS and regulatory standards ... preventative maintenance (PM) & predictive maintenance (PDM) practices to ensure compliance (cGMP) with company policies and appropriate regulatory … more
