- BMO Financial Group (Chicago, IL)
- …required to mitigate Non-Financial Risk exposures, to comply with regulatory requirements, Corporate Policies, Corporate Standards and other published directives ... stakeholder leadership with respect to trade-offs. + Speaks authoritatively with regulatory officials with respect to existing controls, the risk management… more
- Highmark Health (Springfield, IL)
- …consultation and analytic support to assigned functional areas. Continuously monitors regulatory changes, legislative efforts, industry trends, and/or contract ... special interest groups, advocacy agencies, CMS, state Medicare/Medicaid administrators, and other regulatory bodies such as DPW. + Ensure or participate in ensuring… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …of projects. + Communicate effectively with cross-functional teams (eg, R&D, Regulatory , Manufacturing) to ensure seamless product development. + Provide guidance on ... quality aspects across regulatory filings related to specifications, acceptance criteria, and stability...partnerships by serving as lead point of contact with contract manufacturing organizations and external collaborators. + Ensure compliance… more
- Fujifilm (Springfield, IL)
- …Division General Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with respect to ... healthcare regulatory compliance, anti-kickback statutes, the False Claims Act, US...efficiency, consistency, and alignment of contracting practices and best-in-class contract terms across the Legal Department and the HLUS… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, ... and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized… more
- Robert Half Finance & Accounting (Chicago, IL)
- …a wide range of responsibilities including accounting, compliance, forecasting, and regulatory reporting. This role will also involve technical analysis including ... and TOTIT obligations as well as scenario modeling. . Support the regulatory filing process to ensure accurate and timely reporting. Responsibilities include… more
- AbbVie (North Chicago, IL)
- …advance medicines to our patients. Responsibilities + Provide expertise/lead regulatory submission and product life-cycle management strategy planning and ... drive alignment with functional management. Partner with other functions (Clinical, Regulatory , Patient Safety, or GMA) to create development strategies for assigned… more
- ThermoFisher Scientific (Mount Prospect, IL)
- …including contract manufacturing, packaging, or distribution is required. + Regulatory Expertise: Extensive understanding of cGMP, FDA, EMA, and other global ... The Site Quality Head ensures that quality systems are successfully implemented, regulatory expectations are consistently met, and business goals are achieved. This… more
- AbbVie (North Chicago, IL)
- …advance medicines to our patients. Responsibilities: + Provide expertise/lead regulatory submission and product life-cycle management strategy planning and ... drive alignment with functional management. Partner with other functions (Clinical, Regulatory , Patient Safety, or GMA) to create development strategies for assigned… more
- Edwards Lifesciences (Chicago, IL)
- …with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize ... trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements + Develop and deliver technical training on GCPs, protocols,… more
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