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 StrategyGurnee, 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.
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 CentralChicago, 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.
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.
NewSenior 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.
NewSenior 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.
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 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.
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.
NewSenior Manager, Global Scientific & Regulatory Affairs (SRA) Center of Excellence (CoE) Mars IncSenior 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 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.