NewSenior Manager Regulatory Strategy LundbeckSenior Manager Regulatory StrategyPleasant Prairie, WI$165,000–$185,000 / yearManages the processing of regulatory submissions with Strategy leadership and operational support; ensures submissions are prepared in compliance with regulatory requirements and guidance documents; ensures that appropriate review and approval is obtained. Working with US regulatory management and the Global Regulatory Lead, serves as US subject matter expert to support strategy development and execution for assigned products.
Adverse Event Specialist MedlineAdverse Event SpecialistMundelein, IL$67,000–$101,000 / yearEvaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision. Work cross‑functionally with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.
NewMedical Reviewer Safety Reviewer - Remote CollaberaMedical Reviewer Safety Reviewer - RemoteNorth ChicagoRemote$30–$35 / hourTemporaryContractorProvides timely assessment of reported clinical trial data and participates in applicable safety surveillance activities for assigned studies including review of labs, vital signs, cardiac, medications, medical history, and can communicate with Study Lead any findings.?? . May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification.
NewSenior Medical Science Liaison Rare Epilepsies- North Central LundbeckSenior Medical Science Liaison Rare Epilepsies- North CentralDeerfield, IL$180,000–$220,000 / yearStrategic Scientific Engagement & Insight Generation: Establishes and sustains deep, longitudinal scientific partnerships with Key Opinion Leaders (KOLs), Centers of Excellence, and investigators working in rare epilepsies. This role serves as a strategic pre-launch scientific partner to external experts and internal stakeholders, generating high-quality, actionable insights that inform evidence strategy, disease education, portfolio decision-making, and launch readiness.
Regulatory Affairs Associate I Actalent IncRegulatory Affairs Associate INorth Chicago, IL$66–$72 / hourProject manage Exception Reports in partnership with cross-functional stakeholders to identify root causes, define corrective and preventive actions, and drive continuous improvement in business processes. Collaborate with Regulatory Affairs leaders, Business Process Owners, Quality, and other functional partners to ensure issue management activities are well-coordinated, effective, and aligned with organizational objectives.
Regulatory Affairs Associate Katalyst Healthcares & Life SciencesRegulatory Affairs AssociateNorth Chicago, ILThis role oversees the Regulatory Affairs Issue and CAPA Management system (RAIM), triages issue records, escalates issues to Exception Reports when warranted, and partners cross-functionally to drive process improvements. Through collaboration with functional and cross-functional stakeholders, the position also supports inspection readiness and audit/inspection response activities, and management of change plans for legacy company integrations into Regulatory Affairs business processes.
Regulatory Affairs Associate Katalyst HealthCares & Life Sciences IncRegulatory Affairs AssociateNorth Chicago, ILThis role oversees the Regulatory Affairs Issue and CAPA Management system (RAIM), triages issue records, escalates issues to Exception Reports when warranted, and partners cross-functionally to drive process improvements. Through collaboration with functional and cross-functional stakeholders, the position also supports inspection readiness and audit/inspection response activities, and management of change plans for legacy company integrations into Regulatory Affairs business processes.
Regulatory Affairs Associate Karwell TechnologiesRegulatory Affairs AssociateNorth Chicago, ILWhether you're a recent graduate or early in your Regulatory Affairs career, this role provides valuable exposure to regulatory operations, global submissions, data governance, and cross-functional collaboration within a highly respected life sciences environment. Partner with global and regional teams to ensure regulatory submissions and correspondence are accurately documented and aligned across markets.
Director, Head of Regulatory Affairs Allstate Insurance CompanyDirector, Head of Regulatory AffairsIL$187,000–$260,000 / yearReporting to the SVP, Government & Industry Relations, the Head of Regulatory Affairs establishes enterprise regulatory governance, oversees examinations, filings, and regulatory matters, leads market conduct and remediation strategies, and develops predictive intelligence capabilities to identify emerging risks, anticipate regulatory trends, and mitigate potential business impacts before they escalate into enforcement actions or material issues. Develop and maintains a comprehensive regulatory risk dashboard that tracks complaint ratios by state, line of business, and product against industry benchmarks (NAIC complaint database), along with examination findings, MCAS trends, legislative activity heat maps, and aging of open regulatory inquiries.
Associate II, Regulatory Affairs ICU Medical Inc.Associate II, Regulatory AffairsLake Forest, IL$67,500–$96,750 / yearWith the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings. Excellent knowledge of publishing tools, global submission validation tools, Document Management systems, Toolbox, electronic submission gateways, MS Word, Adobe Acrobat including creating PDF hyperlinks and other support software.
Regulatory Affairs Lead Oncology Associate Director Astellas Pharma IncRegulatory Affairs Lead Oncology Associate DirectorNorthbrook, ILResponsibilities and Accountabilities: Actively seeks out knowledge of overall corporate strategy and other general factors that affect the regulatory positions taken within the company, and with the FDA and global health authorities, and incorporates this knowledge in interactions with others. Works closely with other individuals/groups within Regulatory Affairs to influence others to ensure departmental consistency and identifies options for risk discussions.
Senior Associate, Regulatory Affairs (Hybrid - Lake Forest, IL) ICU Medical Inc.Senior Associate, Regulatory Affairs (Hybrid - Lake Forest, IL)Lake Forest, IL$97,500–$139,750 / yearWith the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings. Our focus allows us to bring you: Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
Senior Associate, Regulatory Affairs ICU Medical IncSenior Associate, Regulatory AffairsLake Forest, IL$97,500–$139,750 / yearWith the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings. Our focus allows us to bring you: Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
Senior Associate Regulatory Affairs Submission Management - Hybrid AbbVie IncSenior Associate Regulatory Affairs Submission Management - HybridNorth Chicago, ILWith input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. Responsibilities: Manages medium to high impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
Senior Manager, Regulatory Affairs AMETEK IncSenior Manager, Regulatory AffairsMount Prospect, ILEnsure compliance with applicable regulatory requirements, including FDA QMSR, EU Medical Device Regulation (MDR), Medical Device Reporting (MDR), UDI/GUDID, product and site registrations, cybersecurity requirements, Software as a Medical Device (SaMD), CE Marking, labeling requirements, adverse event reporting, field corrective actions, Declaration of Conformity, Buy American Act (BAA), Build America Buy America Act (BABAA), and Certificates of Free Sale. The successful candidate serves as a strategic advisor and subject matter expert on regulatory matters, drives continuous improvement initiatives, supports regulatory inspections and audits, and proactively identifies emerging regulatory trends and requirements that may impact Rauland products, processes, and business objectives.
Director Regulatory Affairs Data Standards and Governance AbbVie IncDirector Regulatory Affairs Data Standards and GovernanceNorth Chicago, ILSupport the Product Data Office initiative to establish enterprise-level data governance, improve data quality and interoperability to resolve key business challenges including Regulatory and Supply Chain data integration and Change Control processes. Builds and uses AbbVie's Data Catalogue to drive clear definitions for critical data elements, supporting data lineage verification and mapping properties across systems for interoperability of Regulatory data across the product lifecycle.
Manager Regulatory Affairs Submission Management - Hybrid AbbVie IncManager Regulatory Affairs Submission Management - HybridNorth Chicago, ILResponsibilities: Independently manages high impact (with respect to internal visibility, risk, complexity and criticality)submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Associate Director Regulatory Affairs Advertising & Promotion - Digital & Corporate Communications AbbVie IncAssociate Director Regulatory Affairs Advertising & Promotion - Digital & Corporate CommunicationsILApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Manager Regulatory Affairs Global Reg Strategy US & Canada AbbVie IncManager Regulatory Affairs Global Reg Strategy US & CanadaNorth Chicago, ILApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Regulatory Affairs Specialist DEL MEDICAL IncRegulatory Affairs SpecialistBloomingdale, ILManage the overall development and approval process for assigned documents (CEP, CER, etc.) within timelines, including documentation generation, initiation of the review process, discussions on proposed revisions, and document completion in collaboration with other team members. You will work cross-functionally with Engineering, Quality, Manufacturing, and Leadership teams to ensure our products meet all applicable regulatory requirements throughout the product lifecycle.