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 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.
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.
NewRegulatory 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.
NewSenior Manager Regulatory Affairs Global Reg Strategy US & Canada - Immunology Hybrid AbbVie IncSenior Manager Regulatory Affairs Global Reg Strategy US & Canada - Immunology HybridNorth 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 thisposting 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 anduntil 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.
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.
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.
Sr Regulatory Affairs Specialist- Medical Devices SunstarSr Regulatory Affairs Specialist- Medical DevicesSchaumburg, IllinoisWork with Regional Director, Regulatory Affairs to ensure rapid and timely approval of new products and continued regulatory support of products marketed within and outside the United States, including labeling guidance and adequate deliverables required for technical file and US FDA requirements. Under supervision, coordinate, compile, and submit regulatory applications to competent authorities, notified bodies, regulatory agencies, and international business partners, including the preparation of key market international documents, including technical files and 510(k)’s.
Corporate Counsel II - Regulatory Affairs ALDICorporate Counsel II - Regulatory AffairsAurora, IllinoisResearches, monitors, assesses, and communicates emergent legal trends, new legal and regulatory issues and laws, legislation, regulations, agency guidance, rulemaking activity, enforcement developments, and court decisions in multiple jurisdictions to drive strategy and operational goals; identifies and communicates impactful updates and business implications to direct leader and relevant business units. This role is particularly well-suited for an attorney with experience advising on sustainability and environmental compliance initiatives, including packaging regulations, extended producer responsibility (EPR) programs, waste and recycling requirements, climate-related regulatory developments, and other emerging ESG obligations.
NewSenior Associate Regulatory Affairs - Chemistry Manufacturing & Control CMC - Hybrid AbbVie IncSenior Associate Regulatory Affairs - Chemistry Manufacturing & Control CMC - HybridNorth Chicago, ILThe Senior Associate, RA CMC is responsible for ensuring RA-CMC post approval change objectives are met by project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. 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.
Regulatory Affairs Manager Kobayashi Healthcare International IncRegulatory Affairs ManagerNiles, ILEnsure timely submission of required reports, including Serious Adverse Event Reports (SAERs), Medical Device Reports (MDRs), and other applicable regulatory notifications. Manage and oversee adverse event reporting programs for OTC drug products, dietary supplements, cosmetics, and medical devices in accordance with FDA requirements.
Senior Manager, Global CMC Regulatory Affairs Xeris PharmaceuticalsSenior Manager, Global CMC Regulatory AffairsChicago, IL$155,750–$213,600 / yearStarting pay is determined based on a variety of factors, including the role, job-related knowledge, skills, experience, education, internal equity, market data, and the location of the role, where applicable. Develop and create CMC regulatory strategy for integrated development plans and long-term planning at a cross-functional level for product(s), consistent with the corporate and project objectives.
Senior Manager, Global CMC Regulatory Affairs Xeris Biopharma Holdings IncSenior Manager, Global CMC Regulatory AffairsChicago, IL$155,750–$213,600 / yearStarting pay is determined based on a variety of factors, including the role, job-related knowledge, skills, experience, education, internal equity, market data, and the location of the role, where applicable. Develop and create CMC regulatory strategy for integrated development plans and long-term planning at a cross-functional level for product(s), consistent with the corporate and project objectives.
Regulatory Affairs Specialist - Medical Device iMPact Business GroupRegulatory Affairs Specialist - Medical DeviceCary, ILEvaluating proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposing plans or strategies for changes that do not require submissions. Evaluating the regulatory environment and contributing to internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
Corporate Counsel II - Regulatory Affairs Aldi IncCorporate Counsel II - Regulatory AffairsAurora, ILResearches, monitors, assesses, and communicates emergent legal trends, new legal and regulatory issues and laws, legislation, regulations, agency guidance, rulemaking activity, enforcement developments, and court decisions in multiple jurisdictions to drive strategy and operational goals; identifies and communicates impactful updates and business implications to direct leader and relevant business units. This role is particularly well-suited for an attorney with experience advising on sustainability and environmental compliance initiatives, including packaging regulations, extended producer responsibility (EPR) programs, waste and recycling requirements, climate-related regulatory developments, and other emerging ESG obligations.
Manager, Regulatory Affairs Xeris Biopharma Holdings IncManager, Regulatory AffairsChicago, IL$120,000–$165,000 / yearStarting pay is determined based on a variety of factors, including the role, job-related knowledge, skills, experience, education, internal equity, market data, and the location of the role, where applicable. This role will be responsible for preparing and reviewing regulatory submissions, contributing to regulatory strategy, and interacting with internal and external stakeholders to ensure compliance with global health authority requirements.
Director of Individual Insurance Compliance & Regulatory Affairs Alera GroupDirector of Individual Insurance Compliance & Regulatory AffairsChicago, IllinoisThe ideal candidate brings deep expertise in Medicare and individual insurance compliance, strong regulatory knowledge, and experience building scalable compliance frameworks within complex, multi-site insurance or healthcare environments. This role will lead the development, implementation, and oversight of scalable compliance programs supporting Medicare Advantage, Medigap, Part D, ACA, and ancillary insurance products across a national distribution platform.
Regulatory Affairs Manager, Comprehensive Cancer Center University of ChicagoRegulatory Affairs Manager, Comprehensive Cancer CenterChicago, IL$65,000–$90,000 / yearActs as the primary regulatory liaison for external sites participating in clinical research projects coordinated by the University of Chicago, including distribution of protocol documents and amendments; review of site consent forms; collection of site specific essential documents, including IRB approvals, Form FDA 1572, staff qualifications and signatures, etc. and maintenance of up-to-date regulatory files for external participating sites. The Comprehensive Cancer Center comprises over 190 faculty members from twenty departments, with members currently being awarded over $47 million in total direct costs in peer-reviewed cancer research grants, and $28 million in non-peer-reviewed grants and contracts.