NewRegulatory Specialist # 26-22388 US Tech Solutions, Inc.Regulatory Specialist # 26-22388Reynoldsburg, OHResponsibilities Individual contributor Responsible for providing day to day global regulatory support & execution for the Regulatory Affairs department to aid in the successful launch and lifecycle of compliant products from ingredient review to label assessment to government product submissions, documentation, and related dossiers to ensure accuracy and completeness for global product launches. US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions.
Research Scientist Immunology -- Nutrition - Columbus, OH Abbott LaboratoriesResearch Scientist Immunology -- Nutrition - Columbus, OHColumbus, OH$99,300–$198,700 / yearSummarize and report results to internal stakeholders including quality assurance, regulatory affairs, medical safety and R&D teams Interface with internal and external stakeholders including key opinion leaders within the allergen field and present data. In Research & Development (R&D) our ambition is to provide innovative high-quality products, creating sustainable value, delivering superior user experience and enhancing health outcomes at all stages of life.
Strategic Content Planner, Pediatric Nutrition, Internal Agency - Columbus, OH Abbott LaboratoriesStrategic Content Planner, Pediatric Nutrition, Internal Agency - Columbus, OHColumbus, OH$99,300–$198,700 / yearIn today’s fragmented media landscape, this role ensures that every idea, message, and execution works together to create a unified brand experience—driving results and building lasting connections with audiences. Connect consumer insights, brand strategy, and channel execution into cohesive campaign frameworks to ensure alignment across channels – digital, social, experiential, traditional and earned media.
Analyst, Regulatory Affairs and Compliance The Scotts Miracle-Gro CoAnalyst, Regulatory Affairs and ComplianceMarysville, OH$111,500–$131,200 / yearBe part of something bigger by joining one of our Employee Resource Groups focusing on diversity and inclusion, family, education and sustainability: Scotts Women's Network, Scotts Black Employees' Network, Scotts Veterans Network, Scotts Young Professionals, Scotts Pride Network (GroPride), Scotts Associates for a Greener Earth (SAGE), Scotts Family TREE and our Associate Boards. As a regulatory leader, you will directly manage a team of 5-10 regulatory professionals, driving process improvements, overseeing complex registration projects, and serving as the primary liaison with regulatory agencies (EPA and state departments of agriculture).
Senior Director of Regulatory Affairs Cleveland DiagnosticsSenior Director of Regulatory AffairsCleveland, OhioReports to: Chief Medical Officer Job Overview The Senior Director of Regulatory Affairs will provide strategic and operational leadership for regulatory affairs activities supporting Cleveland Diagnostics’ in vitro diagnostic (IVD) and laboratory developed test (LDT) product portfolio, including tests/assays intended for early cancer detection and other clinical indications. The Senior Director will serve as a regulatory leader for FDA-regulated IVD products, including PMA, PMA supplement, 510(k), amendment, annual report, and post-approval submission activities, as well as international regulatory documentation, including IVDR Technical Documentation and other jurisdictional requirements where applicable.
Strategist, Regulatory Affairs ClinChoice IncStrategist, Regulatory AffairsCincinnati, OHPrepare and/or review letters of authorization, cover letters for registration certificates, declarations, power of attorney, and other regulatory documentation to ensure accuracy, appropriateness, and consistency of documents intended for various global regulatory submissions. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel.
Strategist, Regulatory Affairs ClinChoiceStrategist, Regulatory AffairsCincinnati, OHPrepare and/or review letters of authorization, cover letters for registration certificates, declarations, power of attorney, and other regulatory documentation to ensure accuracy, appropriateness, and consistency of documents intended for various global regulatory submissions. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel.
Manager, Regulatory Affairs ScottsMiracle-GroManager, Regulatory AffairsMarysville, OhioBe part of something bigger by joining one of our Employee Resource Groups focusing on diversity and inclusion, family, education and sustainability : Scotts Women’s Network, Scotts Black Employees’ Network, Scotts Veterans Network, Scotts Young Professionals, Scotts Pride Network (GroPride), Scotts Associates for a Greener Earth (SAGE), Scotts Family TREE and our Associate Boards. As a regulatory leader, you will directly manage a team of 5–10 regulatory professionals, driving process improvements, overseeing complex registration projects, and serving as the primary liaison with regulatory agencies (EPA and state departments of agriculture).
Manager of Regulatory Affairs Aprecia PharmaceuticalsManager of Regulatory AffairsMason, OhioRegulatory responsibilities also include post-approval drug product reporting activities such as completing regulatory impact assessments for commercial drug product changes, filing labeling and promotional material submissions, supporting adverse event reporting activities and developing appropriate regulatory strategies to support business objectives. Duties/Responsibilities 1 Work with Product Development, Technical Services, Analytical, Project Management, Quality Assurance and other staff contributing to the preparation of CMC (Chemistry, Manufacturing, and Controls) and/or clinical, and regulatory submissions.
Senior Manager, Regulatory Affairs ADMA Biologics IncSenior Manager, Regulatory AffairsColumbus, OHResponsible for the preparation, review, presentation, and publishing of all FDA submissions to assure accuracy and completeness of submission documents, which includes but is not limited to meeting requests/briefing packages and presentations to the FDA (e.g., preIND/pre-BLA, end-of-phase II, Type A,B or C, and advisory committee meetings), Investigational New Drug Applications (INDs), Biologic License Applications (BLAs), Orphan Drug Applications, Marketing and Promotional Materials, Product Listing and Establishment License Applications, and other related documents or CMC supplement submissions. Essential Functions and Responsibilities: Provides accurate and timely regulatory guidance to Management, Process Development, Analytical Development, Manufacturing, and the Quality Assurance/Quality Control staff while maintaining frequent contact with the Head of Regulatory Affairs.
Regulatory Affairs Specialist Consumer Chemicals Employment SolutionsRegulatory Affairs Specialist Consumer ChemicalsColumbus, OHThis is a direct hire opportunity for someone who takes pride in careful, thorough work, enjoys navigating complex compliance frameworks, and wants to be the go-to expert on EPA registrations, labeling, and state disclosure requirements. Working knowledge of EPA FIFRA registrations, SDS/GHS, SB 258, Prop 65, CARB, and FTC claim substantiation frameworks.
Lead Regulatory Affairs Specialist ColteneLead Regulatory Affairs SpecialistCuyahoga Falls, OhioThis includes providing regulatory guidance, registering products, evaluating engineering changes with respect to regulatory compliance, maintaining required regulatory records and reports and interacting with regulatory agencies and notified bodies. Interface with cross-functional teams on large and small projects to ensure products are transferred to production in accordance with cGMPs, QSRs, MDRs and the Quality Management System.
Regulatory Affairs Manager - Labeling Cardinal Health IncRegulatory Affairs Manager - LabelingDublin, OHRemote$105,100–$150,100 / yearSymbol and Mark Management: Ensure the correct application of environmental symbols and marks, including those for the WEEE Directive, battery directives (e.g., crossed-out wheeled bin), recycling (e.g., "Green Dot," Mobius loop), and packaging material identification. Risk Management: Ability to apply risk management principles (ISO 14971) to the labeling process, identifying and mitigating risks associated with labeling errors, such as product recalls, shipping holds, or regulatory enforcement actions.
Regulatory Affairs Specialist Applied Medical Technology IncRegulatory Affairs Specialistbrecksville, OHPrepare and submit regulatory documentation, such as FDA 510(k) premarket notifications, to regulatory agencies, including FDA, Notified Bodies, and Authorized Representatives. Prepare, maintain, and submit, when necessary, European Medical Device Directive and European Medical Device Regulation compliant Technical Files.
Regulatory Affairs Specialist Applied Medical Technology, Inc.Regulatory Affairs SpecialistBrecksville, OHPrepare and submit regulatory documentation, such as FDA 510(k) premarket notifications, to regulatory agencies, including FDA, Notified Bodies, and Authorized Representatives. Prepare, maintain, and submit, when necessary, European Medical Device Directive and European Medical Device Regulation compliant Technical Files.
Regulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaOH$56,604–$88,443 / yearDevelop and deliver employee environmental, health, and safety (EHS) awareness and training programs to ensure compliance with applicable federal, state, and international regulations, including OSHA, OSHA State Plans (e.g., Cal/OSHA), DOT, IATA, IMO, and EPA requirements. Proficient in Microsoft Office applications, including PowerPoint, and experienced with project management methodologies and tools commonly used in the medical device or pharmaceutical industries.
Federal Legislative & Regulatory Affairs Director Interstate Gas SupplyFederal Legislative & Regulatory Affairs DirectorOhioExperience working with FERC, PJM, RTO/ISO market structures, interstate natural gas, or wholesale electricity markets strongly preferred. Lead IGS's regulatory and legislative initiatives related to FERC, PJM, wholesale electricity markets, interstate natural gas, transmission policy, and related federal energy issues.
Packaging Compliance Manager/Packaging Engineer in Regulatory Affairs - Columbus OH/Abbott Park, IL (internal OUS can apply) AbbottPackaging Compliance Manager/Packaging Engineer in Regulatory Affairs - Columbus OH/Abbott Park, IL (internal OUS can apply)Columbus, Ohio$99,300–$198,700 / yearDepending on specific role, the Regulatory Affairs Project Manager may be involved in various regulatory activities (market access activities, regulatory submissions/registrations; evaluation of product and/or packaging and manufacturing changes for regulatory implications; maintaining compliance documentation, oversight of systems related to product and/or packaging management, project management, process improvement, etc.). Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Packaging Compliance Manager/Packaging Engineer in Regulatory Affairs - Columbus OH/Abbott Park, IL (internal OUS can apply) Abbott LaboratoriesPackaging Compliance Manager/Packaging Engineer in Regulatory Affairs - Columbus OH/Abbott Park, IL (internal OUS can apply)Columbus, OH$99,300–$198,700 / yearDepending on specific role, the Regulatory Affairs Project Manager may be involved in various regulatory activities (market access activities, regulatory submissions/registrations; evaluation of product and/or packaging and manufacturing changes for regulatory implications; maintaining compliance documentation, oversight of systems related to product and/or packaging management, project management, process improvement, etc.). Supervisory/Management Responsibilities (Influence/Impact/Leadership): Provide leadership without direct authority (i.e., project leader) and provide direction and guidance to exempt and non-exempt personnel who exercise significant latitude and independence in their assignments.
Regulatory Affairs Specialist GlobalchannelmanagementRegulatory Affairs SpecialistWestlake, OhioRegulatory Affairs Specialist duties: Responsible for classifying new and existing products according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Pre-Authoring of Safety Data Sheets (SDS) and labels in accordance to Haz Comm 2012 and WHMIS 2015.