NewRegulatory 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.
NewRegulatory 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.
NewRegulatory 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.
NewRegulatory Affairs Associate III # 26-21316 US Tech Solutions, Inc.Regulatory Affairs Associate III # 26-21316North 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.
NewRegulatory Affairs Associate I K3 InnovationsRegulatory Affairs Associate INorth Chicago, ILMonitors activity in COSMOS (Regulatory Information Management solution) for assigned products and activities, including ensuring completeness and accuracy of data. Required Education: Bachelor's degree in related life sciences (pharmacy, biology, chemistry, medical technology pharmacology).
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.
NewAssociate II, Regulatory Affairs ICU Medical IncAssociate 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.
Associate Director International Regulatory Affairs Advertising & Promotion-Hybrid AbbVie IncAssociate Director International Regulatory Affairs Advertising & Promotion-HybridILThe Associate Director will be responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching global regulatory strategy and global brand plan and leads the international regulatory strategy for the assigned marketed and development compounds. 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.
Staff Regulatory Affairs Specialist (Pharmaceutical Products) StrykerStaff Regulatory Affairs Specialist (Pharmaceutical Products)Cary, IllinoisHowever, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. Experience preparing, authoring, or supporting drug regulatory submissions, including submissions for product approvals, post-approval changes, or lifecycle management activities.
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.
NewSenior 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.
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.
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.