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 StrategySchaumburg, 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 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.
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.
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.
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.
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 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.
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.
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.
Senior Manager - Regulatory Affairs Covista IncSenior Manager - Regulatory AffairsChicago, IL$80,336.75–$145,077.09 / yearUnder the general direction of the Senior Director of Regulatory Affairs, the Senior Manager, Regulatory Affairs is responsible for ensuring that all Covista advertising, marketing, public- and student-facing communications for all Covista institutions and business units are written in compliance with state and federal regulatory agency requirements. Due to the importance, high visibility of marketing, risks and potential impact related to misrepresentation, the incumbent must have the business acumen to accurately interpret often ambiguous regulations and partner with marketing and operations leaders to accept guidance on marketing practices.
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.
Quality & Regulatory Affairs LancesoftQuality & Regulatory AffairsGlenview, ILRemote$18This position requires the ability to handle complexity, work independently, and manage multiple projects under tight timelines with a strong drive for results and the ability to bring projects to completion. Investigates customer/consumer complaints using root cause analysis and works with department managers to determine what corrective and preventive actions are necessary.
NewSpectrum and Regulatory Affairs Intern ShureSpectrum and Regulatory Affairs InternNiles, IllinoisRemote$23–$43 / hourInternThese studies will be based on modelling and simulation of relevant wireless systems and scenarios , requiring from the intern the familiarization with an existing Matlab-based tool, the implementation of specific models (radio propagation models, antenna patterns) and study scenarios in the tool, and the performance of sharing studies . Modeled by extensive market analysis and economic best practices, Shure offers competitive intern compensation that is reviewed and adjusted annually by our Total Rewards Team to attract, hire, and retain the industry’s top intern talent.
NewSr Manager, Regulatory Affairs & Quality Assurance – Surgical Robotics SysmexSr Manager, Regulatory Affairs & Quality Assurance – Surgical RoboticsLincolnshire, Illinois$126,000–$175,000 / yearOur agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory. to build a promising future. 4. Provide regulatory guidance and leadership to cross-functional departments or development project teams regarding design, development, evaluation, or marketing (ad/promo) of products.