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Regulatory 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. Reporting to this Position :No direct reports Travel :Position may require up to 10% travel Work Shift :This position works days, but may include extended hours and weekend work when required Knowledge, Skills and Abilities : Excellent oral and written communication skills.

Aprecia Pharmaceuticals

Manager of Regulatory Affairs

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ADAPTED_NOW

Continuously monitor to ensure that a safe and sanitary physical environment is maintained throughout the facility; that all equipment is maintained and functions properly; and that adequate and appropriate inventory levels of all supplies are available and used correctly. STAFF DEVELOPMENT/ RETENTION Ensure all staff meet required qualifications for position held and perform duties within limitations established by and in accordance with company policy/procedures, health care professionals practice acts, applicable state and federal laws and regulations.

U.S. Renal Care was founded in 2000 and serves more than 25,000 patients in 335 dialysis facilities in 32 states and the Territory of Guam. We have a unique business model, developing and operating dialysis centers in joint venture partnerships with leading local nephrologists. 

At our core, we exist to serve our patients. In fact, we like to say that we are inspired by our patients. We do our best to provide compassionate care, where and when patients need it.

We wouldn’t be a leading dialysis provider without our leadership team. Each team member brings decades of healthcare and business experience to their roles.

U.S. Renal Care

Dialysis Facility Administrator

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Be 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).

The Scotts Miracle-Gro Company (NASDAQ: SMG) is the leading manufacturer and marketer of branded consumer lawn and garden products in North America. Our products are marketed under some of the most recognized brand names in the industry.
Through our subsidiary Hawthorne Gardening, we are a leading manufacturer, marketer and distributor of nutrients, growing media, advanced indoor garden, lighting and ventilation systems and accessories for hydroponic gardening.
Our brands are trusted to meet unique consumer needs – whether it's products in natural and organic or solutions for indoor and urban gardening. We are constantly listening to our consumers so we can develop the products they need.
We were recently ranked as a Columbus 2020 Top Places to Work.

ScottsMiracle-Gro

Manager, Regulatory Affairs

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Excellent knowledge required of regulatory and cGMP requirements, including in 21 CFR Part 11, Part 210, Part 211, Part 212, Part 314, and other relevant 21 CFR parts and regulatory guidance documents as applied to a sterile injectable drug and oral capsule manufacturing environment. Oversee and perform risk management reviews through products' life cycles and participate in change management internal processes, such as engineering and documentation change control and cross-functional project meetings.

YEAR

Cardinal Health Inc

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The QA/RA Intern assists the QA/RA team with projects and daily tasks associated with maintaining compliance with quality system as required for Medical Device Manufacturers involved with Clean Room Operations, and through support of other functional departments or product staff in assisting the QA/RA Manager. Prepares quality documentation (ERTs, CRTs and Management Review) and reports by collecting, analyzing, and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.

Fortifi

Quality Engineering and Regulatory Affairs Intern

Reports 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.

Cleveland Diagnostics

Senior Director of Regulatory Affairs

Reports 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.

Cleveland Diagnostics Inc.

J-Vers Cloud

You'll serve as the company’s expert in product regulatory compliance, product safety, hazard communication, and customer regulatory support, and will partner with cross functional teams to stand up the Minimum Viable Program (MVP) outlined in the strategic plan and establish the governance, systems, and processes required to protect market access, reduce liability, and support commercial growth. In this newly established role, you'll be responsible for leading a collaborative effort building and executing the company’s global Product Stewardship and Regulatory Affairs program, ensuring adherence to federal, state, and international regulations while enabling business growth, innovation, and risk reduction.

Matrix Adhesives

Product Stewardship & Regulatory Affairs Leader

Problem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make thorough regulatory assessments demonstrating the ability to solve difficult problems and create effective and innovative solutions. Provide centralized regulatory intelligence and governance related to global product registration to interpret and execute on global regulatory requirements, ensuring timely insight and clear guidance to Business Units and Regions to enable compliant growth and market access.

Becton Dickinson and Co

Regulatory Affairs- Senior Manager, Globalization (Registrations)

Partner with internal technical teams and external upstream and downstream stakeholder groups to advance technical infrastructure needs for our users and customers, ensuring a unified approach regarding economic, social and environmental benefits of Google Cloud investments in new and existing markets. In this role, you will be involved in collaborating with Google Cloud and other internal teams to advance Google's Cloud business and technical infrastructure needs, leading government affairs and public policy matters within key state and local markets.

Google LLC

Regional Manager, Google Cloud, Government Affairs and Public Policy

From software to hardware our teams are shaping the future of world-leading hyperscale computing, with key teams working on the development of our TPUs, Vertex AI for Google Cloud, Google Global Networking, Data Center operations, systems research, and much more. Were the driving force behind Googles groundbreaking innovations, empowering the development of our cutting-edge AI models, delivering unparalleled computing power to global services, and providing the essential platforms that enable developers to build the future.

Public Affairs Manager, Regional Data Centers

The State Government Affairs Manager works closely with the External Affairs Director, External Affairs Vice-President, Regulatory Department and Company President by representing the Corporation and its issues before the state legislature, state government, industry, trade, and public advocacy groups. Work Experience requirement listed below: Minimum 6 years experience in community/public affairs, communications or direct related experience in the industry which may include experience with the state legislature, state government or comparable state work.

American Electric Power Co Inc

State Govt Affairs Manager

The State Government Affairs Manager works closely with the External Affairs Director, External Affairs Vice-President, Regulatory Department and Company President by representing the Corporation and its issues before the state legislature, state government, industry, trade, and public advocacy groups. Minimum 6 years experience in community/public affairs, communications or direct related experience in the industry which may include experience with the state legislature, state government or comparable state work.

American Electric Power

Sitting; standing; walking or moving throughout facility; driving; talking; seeing (specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus); hearing; feeling; bending or stooping; squatting or crouching; reaching; kneeling; pushing; pulling; lifting up to 25 lbs. This position provides comprehensive support to the Projects, Commercial, and Operations departments by representing the company in relevant communities and with key stakeholders such as elected officials, regulatory agencies, nongovernmental organizations, and industry associations.

Tallgrass MLP Operations, LLC

Manager-State & Local Public Affairs (East)

10 years’ experience as a Medical Physicist, Scientist, or MD in a clinical hospital or clinical research setting or 3 years of experience as a Medical Physicist, Scientist, or MD in a clinical hospital or clinical research setting plus 7 years of experience in healthcare industry as imaging scientist or research manager. Analyze and communicate technical and clinical product specification requirements from luminaries, market research teams, and via Medical Advisory Boards (MABs) to global business team.

Canon USA & Affiliates

Leader Medical Affairs

Title: Senior Director, Medical Affairs Location: Remote ok, but 1 week/month travel to Cleveland, Ohio Reports to: Chief Medical Officer Job Description: The Senior Director, Medical Affairs will serve as the primary bridge between clinical science, key opinion leaders, payers, and the broader medical community — building the evidence base and clinical credibility that will drive adoption of IsoPSA and our pipeline products. Ability to: sit, stand and/or walk throughout course of day; operate a computer and multitask across many software communication and data entry programs while operating and communicating through telephone device for several hours a day; ability to safely drive a vehicle and travel using appropriate and available mass and/or air transit.

Senior Director, Medical Affairs

This individual will serve as a subject matter expert and strategic business partner, helping assess regulatory risk, guide packaging development and commercialization, maintain compliance processes and documentation, and prepare the organization for emerging packaging regulations. 8+ years of relevant experience in packaging regulatory affairs, food-contact materials, packaging development, quality, compliance, or a related field within food, beverage, consumer packaged goods, or another regulated industry.

Adept Group

Packaging Compliance & Regulatory Manager

Our retail brands include Marzetti dressings and dips, New York Bakery garlic breads, and Sister Schubert's dinner rolls, in addition to exclusive license agreements for Olive Garden dressings, Chick-fil-A sauces and dressings, Buffalo Wild Wings sauces, Arby's sauces, Subway sauces, and Texas Roadhouse steak sauces and frozen rolls. Partner with Packaging R&D and cross-functional teams to integrate regulatory requirements into innovation, commercialization, cost-savings, sustainability, and supplier-change initiatives, including providing regulatory review and approval through applicable stage-gate and change-control processes.

Marzetti Co

FULL_TIME

Partner with Packaging R&D and cross-functional teams to integrate regulatory requirements into innovation, commercialization, cost-savings, sustainability, and supplier-change initiatives, including providing regulatory review and approval through applicable stage-gate and change-control processes. Serving as a subject matter expert and strategic business partner, this role works cross-functionally to assess regulatory risk, guide packaging development and commercialization, maintain compliance processes and documentation, and prepare the business for emerging packaging regulations.

The Marzetti Company

[AW]-iCims

Research and identify new state and regional infrastructure supporting opportunities to support regional or short line freight railroad infrastructure investments, including possible new state level grant programs or state short line tax credits. This could include a demonstrated successful sales assignment with rail freight customers, significant experience in the area of public/private sector relationship management involving rail transportation, or a public agency or position with direct involvement with the rail industry.

Regulatory Affairs Manager Jobs in Ohio

Manager of Regulatory Affairs Aprecia Pharmaceuticals

Dialysis Facility Administrator U.S. Renal Care

Manager, Regulatory Affairs ScottsMiracle-Gro

Manager, Regulatory Affairs Cardinal Health Inc

Quality Engineering and Regulatory Affairs Intern Fortifi

Senior Director of Regulatory Affairs Cleveland Diagnostics

Senior Director of Regulatory Affairs Cleveland Diagnostics Inc.

Product Stewardship & Regulatory Affairs Leader Matrix Adhesives

Regulatory Affairs- Senior Manager, Globalization (Registrations) Becton Dickinson and Co

Regional Manager, Google Cloud, Government Affairs and Public Policy Google LLC

Public Affairs Manager, Regional Data Centers Google LLC

State Govt Affairs Manager American Electric Power Co Inc

State Govt Affairs Manager American Electric Power

Manager-State & Local Public Affairs (East) Tallgrass MLP Operations, LLC

Leader Medical Affairs Canon USA & Affiliates

Senior Director, Medical Affairs Cleveland Diagnostics

Packaging Compliance & Regulatory Manager Adept Group

Packaging Compliance & Regulatory Manager Marzetti Co

Packaging Compliance & Regulatory Manager The Marzetti Company

Asst Vice President, Government Affairs Genesee & Wyoming Inc.

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