Regulatory Affairs Associate I

Job DescriptionJob Description·         What are the top 3-5 skills, experience or education required for this position:·         eCTD submission publishing (advertising and promotional 2253 submissions if possible)·         US regulatory FDA guidelines/CFR submission/regulatory project management Veeva Promomats...

Role: Regulatory Affairs AssociateLocation: Abbott Park, IL 60064Key Responsibilities:Assist in the preparation, review, and submission of regulatory documents for new and existing medical devices.Support the regulatory team in ensuring compliance with U.S. FDA regulations, EU MDR, and other international regulatory standards.Monitor and track the regulatory...

Role: Regulatory Affairs AssociateLocation: Abbott Park, IL 60064Key Responsibilities:Assist in the preparation, review, and submission of regulatory documents for new and existing medical devices.Support the regulatory team in ensuring compliance with U.S. FDA regulations, EU MDR, and other international regulatory standards.Monitor and track the regulatory...

Job DescriptionJob DescriptionWe are looking for Regulatory Affairs Associate for our client in Abbott Park, ILJob Title: Regulatory Affairs AssociateJob Location: Abbott Park, ILJob Type: ContractJob Description:Pay Range: $28.51hr - $33.51hrResponsibilities:As an individual contributor, the function of a Regulatory Affairs Specialist is to provide...

Role: Regulatory Affairs Associate(Medical Devices)Location: Abbott Park, IL - 60064Duration: 12 MonthsThe Regulatory Affairs Specialist ensures regulatory compliance and supports efficient business processes. This role evaluates product and software changes, assists in product registrations, and provides regulatory guidance throughout the product...

Role: Regulatory Affairs Associate(Medical Devices)Location: Abbott Park, IL - 60064Duration: 12 MonthsSkills Looking For:Background in software regulatory requirements, particularly related to USFDA evaluation of software changes.Experience in software quality assurance, validation testing, or defect analysis in a regulated industry (preferably medical...

Job DescriptionJob DescriptionTitle:         Regulatory Affairs AssociateLocation: North Chicago, IL 60064 (100% On-Site Role)Contract: 12 months of contract to start with possible extensionJob Summary:• As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient...

Job DescriptionJob DescriptionCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and...

Job Overview: Xeris Pharmaceuticals, Inc. is seeking a seasoned Regulatory Affairs Director to lead our Advertising and Promotion Regulatory Affairs department. As a key member of the team, you will be responsible for providing strategic guidance on the development and implementation of advertising and promotional materials for pre-launch and commercial...

Madison-Davis, LLC is seeking a highly qualified Head of Regulatory Affairs to join their team in Chicago. The successful candidate will provide Compliance Advisory services to the FCM business line and ensure compliance with regulatory requirements under the SEC, FINRA, NFA, CFTC, and other applicable exchanges.The ideal candidate will have extensive...

About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Analyst to join our team at Adtalem Global Education.Job SummaryThe Senior Regulatory Affairs Analyst will be responsible for interpreting statutes, regulations, and administrative rules of various issuing bodies and developing procedures and processes to assure compliance with those...

Envision Unlimited is seeking a Regulatory Affairs and QA Professional to ensure compliance with Illinois Rule 116 and other state and federal regulations. This role requires a strong understanding of regulatory requirements and experience in quality assurance or compliance in healthcare. If you have a Bachelor's degree in nursing (BSN) or related field and...

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to...

About the RoleThe Director of Regulatory Affairs Strategy will work closely with internal and external partners to develop and implement effective regulatory strategies that enable first-pass approvals. This role requires strong leadership skills, as well as the ability to analyze and interpret complex information and make strategic recommendations.Key...

Apply Job Type Full-time Description About Us:Founded in 2017 and based in Chicago, Meitheal Pharmaceuticals is focused on the development and commercialization of generic injectables and, as of 2022, has expanded its focus to include fertility, biologics, and biosimilars. Meitheal currently markets 50 US Food and Drug Administration...

At Marillac St. Vincent Family Services Inc., we are committed to amplifying the voices of marginalized communities through education and comprehensive programs.We are seeking a highly skilled Regulatory Affairs Specialist to join our team, responsible for overseeing various projects related to Immigration policies and ensuring compliance with regulatory...

Regulatory Affairs Specialist PositionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Jeeter. As a key member of our distribution compliance team, you will be responsible for ensuring that all cannabis distribution activities comply with state and federal regulations.In this role, you will oversee the tracking and reporting...

About the Role\The Associate Director, Regulatory Affairs CMC Post Approval Change Dossier Manager is responsible for ensuring regulatory objectives are met by project managing marketed product variations. This includes authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents.\\Key...

Company OverviewMeitheal Pharmaceuticals is a leading developer and commercializer of generic injectables, with a focus on biologics and biosimilars. With over 50 FDA-approved products across various therapeutic areas, we strive to provide easy access to fairly priced medicines through robust manufacturing, consistent supply, and rapid response to our...

Job OverviewAdtalem Global Education is a leading provider of post-secondary education and professional talent to the healthcare industry. As a Senior Regulatory Affairs Analyst, you will play a critical role in ensuring compliance with federal, state, and internal standards and regulations. This position requires strong organizational, interpersonal, and...