- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC, R&D… more
- Merck & Co. (Rahway, NJ)
- …and devices. The Executive Director, as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls Organization ... is pivotal in fostering alignment and global execution across Regulatory Affairs , R&D, Manufacturing, and our Commercial...and systems are in place to maintain the scientific, technical and regulatory quality of all CMC… more
- Merck & Co. (North Wales, PA)
- …divestment and product withdrawal.Support new technology development.Demonstrate an understanding of regulatory affairs and applies this understanding to the ... for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance… more
- FISI - FUJIFILM Irvine Scientific (Santa Ana, CA)
- …(5) or more years of experience in Technical Support or Customer Service and/or Quality Assurance/ Regulatory Affairs /Compliance, technical and ... from a product compliance perspective. External US Responsibilities Manage and mentor Technical Service InvestigatorsAdvise management, in real time, product … more
- Novo Nordisk Inc. (Miami, FL)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …learn new processes and technologies. Broad knowledge of Clinical Development and Regulatory Affairs requirements Ability to multi-task, work independently, and ... Reporting. Interface with CDS manager/supervisor to assure consistency of technical and process strategies. Acts as a technical...to have a minimum of twelve (12) months of service in current position prior to applying for open… more
- Catalent (Manassas, VA)
- …and SQF Demonstrated leadership in the areas of food safety and plant regulatory affairs ; Strong organizations and leadership skills; ability to analyze ... we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.The Quality Assurance Supervisor… more
- DivIHN Integration Inc (Green Oaks, IL)
- …contact one of our Talent Specialists Meghna at ### Rashi at ### Title: Regulatory Affairs Specialist Location: Abbott Park, IL Duration: 7 Months Description ... role As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support...goals and objectives for projects. Influences middle management on technical or business solutions. May interact with vendors. Exercises… more
- DivIHN Integration Inc (North Chicago, IL)
- …one of our Talent Specialists Meghna at ### Rashi at ### Title: Specialist Regulatory Affairs Duration: 7 Months Location: Abbott Park, IL/ Columbu, OH ... head of a unit/department. Accountability / Scope: As the professional in the Regulatory Affairs function, the individual will assist teams in the registration… more
- DivIHN Integration Inc (Lake Forest, IL)
- …opportunity, please contact one of our Talent Specialists Rashi at ### Title: Regulatory Affairs Associate Jr Location: Lake Forest, IL Duration: 7 Months ... Description Exempt/Non Exempt: Non exemptYears. Duties: Manager regulatory submissions ot ensure timely regulatory approval of medical devices. Monitor changing… more
- FISI - FUJIFILM Irvine Scientific (Santa Ana, CA)
- Overview We are hiring a Clinical Affairs Program Manager. The Clinical Affairs Program Manager will be responsible for the development and generation of ... medical devices and in vitro diagnostic devices. In addition, the Clinical Affairs Program Manager will perform annual activities associated with Post Market… more
- DivIHN Integration Inc (Des Plaines, IL)
- …policies and procedures. Assist the strategy implementation and operations for regulatory affairs activities, including preparing documents and deliverables to ... worldwide. Handles regulatory activities involved in documentation,labeling,field support. Applies regulatory and technical knowledge to a wide variety of… more
- Fidelity TalentSource LLC (Boston, MA)
- …brands and customers. The sweet spot is balancing a trained design-eye and technical mind to innovate and push boundaries within our existing brand guidelines. ... development of these webpagesBridging the gap between graphic design and technical implementation of the About Fidelity external websiteConduct regular user testing… more
- Novanta Inc. (Sarasota, FL)
- …with the departments: Purchasing/ Service / Production/ QM/ Manufacturing Engineering/ Regulatory Affairs / PM and with customers as well as external ... Service Providers Initiating the procurement of materials for sample...sample and prototype builds Initiation, coordination and maintenance of technical product documentation up to the product launch Ensure… more
- Volvo Group (Greensboro, NC)
- …planning process + Participate in Prevost and Volvo governance for regulatory affairs + Work in collaboration with technical publications in the event of ... Project Manager and Regulatory Affairs Location: Greensboro, NC, US,...the globe, our trucks, buses, engines, construction equipment, financial services , and solutions make modern life possible. We are… more
- Actalent (Miami, FL)
- …week) technical writer opportunity with a global biopharmaceutical company! Description: Regulatory Affairs Technical Writer to provide SOP development ... Serve as a primary author for SOPs relating to Regulatory Affairs . * Facilitate the evaluation/creation/revision of...* New/Revised SOPs, Wis that are created you the technical writer in a timely manner. o Facilitate the… more
- Kelly Services (Irvine, CA)
- ** Regulatory Affairs Specialist** The Regulatory Affairs Specialist II, will provide administrative and technical support to regulatory ... in order to facilitate compliance with US and international regulatory requirements. The Regulatory Affairs ...Includes the preparation of key market international documents, including Technical Files. + Work with Management to ensure rapid… more
- Stryker (Portage, MI)
- …improvement in functions. **What you will do** As the **Staff Regulatory Affairs Specialist** , you will engage in technical and scientific regulatory ... to apply? Here are 10 reasons to join our Regulatory Affairs /Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- regulatory -… more
- J&J Family of Companies (Irvine, CA)
- Associate Director, Regulatory Affairs (Cerenovus) - Medical Device Business Services , Inc. - 2406180618W **Description** CERENOVUS, a division of Johnson & ... Location** NA-US-California-Irvine **Organization** Medical Device Business Services , Inc (6029) **Job Function** Regulatory Affairs **Req ID:** 2406180618W more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …Annual Reports and other duties as needed. **Primary responsibilities for the Regulatory Affairs Specialist role:** + Manages dossier compilation for product ... translations, legalizations and apostilled documents with vendors for all North America regulatory affairs . + Coordinates all Annual Reports of Minor Changes… more
