NewMedical Affairs Scientific Communications Director - Movement Disorders LundbeckMedical Affairs Scientific Communications Director - Movement DisordersDeerfield, ILThis individual will partner closely with HEOR, Commercial, Customer insights & analytics, Patient advocacy, Clinical Development, Compliance, Legal, Medical Affairs Operations, and Medical Affairs teams and external experts to ensure scientific materials are accurate, balanced, compliant, and aligned with medical objectives while serving as a scientific communications expert across the organization. Oversee development of all US medical materials, medical slide decks, FAQs, scientific response documents, congress assets, field medical materials, training content, data visualizations, digital scientific content, and other non-promotional medical resources ensuring scientific accuracy, regulatory compliance, and strategic alignment.
NewDirector US Regulatory Strategy LundbeckDirector US Regulatory StrategyDeerfield, IL$200,000–$230,000 / yearThe Director, US Regulatory Affairs Strategy, oversees the implementation of regulatory strategies to ensure the successful development, approval, and lifecycle management of assigned drug and biological products (global products as well as US only products). Serves as primary regulatory contact for alliance product brands, as assigned, including managing cross-functional and multi-leveled governance and alignment meetings.
NewSenior Manager Regulatory Strategy LundbeckSenior Manager Regulatory StrategyWauconda, IL$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.
NewMedical Reviewer/Safety Reviewer - # 26-22286 US Tech Solutions, Inc.Medical Reviewer/Safety Reviewer - # 26-22286VO, ILJob Description: Provides 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.
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.
NewRisk Management Engineer MedlineRisk Management EngineerWork From Home, IL$79,000–$119,000 / yearProvide expertise to the organization including education, technical support, issue resolution, and integration of new or enhanced risk controls to be compliant with EU MDR along with satisfying FDA, ISO 13485, and ISO 14971 risk management related processes throughout the product life cycle. JOB SUMMARY Key contributor within the organization that monitors, maintains, and enhances risk controls by analyzing quality data and major quality events to ensure Medline is properly controlling risks on a global level for medical devices, cosmetics, and OTC drugs.
NewDirector US Patient Advocacy Liaison LundbeckDirector US Patient Advocacy LiaisonDeerfield, IL$240,000–$260,000 / yearCollaborate effectively with Corporate Affairs, Medical Affairs, HEOR, Commercial, Market Access, Clinical Development, and other internal stakeholders to align patient engagement activities with enterprise priorities and to ensure patient perspectives are incorporated into planning processes and organizational initiatives. Partnering cross-functionally with Corporate Affairs, Medical Affairs, Commercial, Market Access, Clinical Development, HEOR, and other stakeholders, the Director serves as a trusted advisor on patient advocacy, stakeholder engagement, and emerging patient needs.
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 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 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 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.
Regulatory Affairs Specialist Sotera HealthRegulatory Affairs SpecialistOak BrookWith a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. TRAINING REQUIRED: Regulatory Affairs Specialists must understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes.
Regulatory Affairs Specialist Sotera Health CoRegulatory Affairs SpecialistOak Brook, IL$63,000–$95,000 / yearWith a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. TRAINING REQUIRED: Regulatory Affairs Specialists must understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes.
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.
Senior Manager, Global Scientific & Regulatory Affairs (SRA) Center of Excellence (CoE) MarsSenior Manager, Global Scientific & Regulatory Affairs (SRA) Center of Excellence (CoE)Chicago, IllinoisPre-Regulatory" Intelligence Frameworks: Design and govern the organizational frameworks, processes and channels required to systematically capture "pre-regulatory" insights (such as emerging scientific trends, shifts in government risk assessment endpoints, and novel methodologies) from internal technical subject matter experts and regional teams. By collaborating with an expansive, matrixed network of senior business leaders, technical subject matter experts and regional SRA teams, the Senior Manager designs robust frameworks that integrate seamlessly within enterprise level risk management systems to assess financial and operational impacts.
Senior Manager, Global Scientific & Regulatory Affairs (Sra) Center Of Excellence (Coe) MarsSenior Manager, Global Scientific & Regulatory Affairs (Sra) Center Of Excellence (Coe)Chicago, ILPre-Regulatory" Intelligence Frameworks: Design and govern the organizational frameworks, processes and channels required to systematically capture "pre-regulatory" insights (such as emerging scientific trends, shifts in government risk assessment endpoints, and novel methodologies) from internal technical subject matter experts and regional teams. By collaborating with an expansive, matrixed network of senior business leaders, technical subject matter experts and regional SRA teams, the Senior Manager designs robust frameworks that integrate seamlessly within enterprise level risk management systems to assess financial and operational impacts.
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.