- Grifols Shared Services North America, Inc (Clayton, NC)
- …more than 110 countries and regions. **Summary:** Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish ... on labeling, labeling requirements, and implementation. Coordinate and submit all regulatory documentation for establishment of new / changed local market… more
- Terumo Aortic (Sunrise, FL)
- Regulatory Affairs Associate II Date: Nov 16, 2025 Req ID: 5116 Location: sunrise, FL, US Company: Department: At Terumo Aortic, our mission is to transform the ... lives of patients in over 100 countries worldwide. www.terumoaortic.com JOB TITLE Regulatory Affairs Associate II DEPARTMENT Regulatory Affairs JOB CODES Exempt… more
- Mondelez International (East Hanover, NJ)
- …are achieved with high quality results and alignment with Legal, Quality , Category managers and Regulatory leads. **Education / Certifications:** Master's ... Rights: Workplace Discrimination is Illegal **Job Type** Regular Scientific Affairs & Regulatory Affairs Product Quality , Safety and Compliance At Mondelēz… more
- Abbott (Alameda, CA)
- …requirements. + Complies with applicable US Food and Drug Administration ( FDA ) and international regulatory requirements, Company policies, operating procedures, ... working mothers, female executives, and scientists. **The Opportunity** This **Principal Regulatory Affairs Specialist - APAC** position will work on-site at our… more
- Parexel (Annapolis, MD)
- …and evaluating clinical sections of regulatory applications. + Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master ... shape it. As a **Senior/Vice President, Technical** on our Regulatory Strategy (RS) team, you'll be at the forefront...activities as well as facilitate business decisions + Produces quality work that meets the expectations of RS and… more
- West Pharmaceutical Services (Exton, PA)
- …for CE Marking, and technical packages. The Sr. Specialist ensures timely and high- quality execution of all regulatory deliverables. In addition, the Sr. ... of relevant experience + 2+ years of medical device regulatory experience preferred + Experience with US FDA...detail with planning, time management and organizational skills + Regulatory compliance competency including Quality Systems +… more
- Lilly (Indianapolis, IN)
- …reporting, Illegitimate Product Report - Form 3911 per DSCSA) and Global regulatory reporting of Quality /safety/compliance issues** + Works with numerous ... US and OUS: Includes networking with Supply chain, Global Quality Leaders, Senior Management, Legal, Regulatory , Global...to determine the need and document the decision for FDA reporting or for notification to OUS regulatory… more
- Post Holdings Inc. (St. Louis, MO)
- …strategies and processes + Oversee and direct the legal aspects of all FDA , USDA, State Attorneys General, and international regulatory authority related matters ... + Counsel business teams on the development and management of the regulatory and quality documentation infrastructure + Oversee and direct the legal aspects of… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and compliance issues, ensuring that documents meet the highest standards of quality and compliance. * Coordinate and prepare regulatory labeling documents ... needed for regulatory labeling submissions. * Assist with FDA interactions, such as labeling negotiations, on assigned projects/products. * Interact with Global… more
- ThermoFisher Scientific (Wilmington, NC)
- …programs and operational practices. + **Stakeholder Alignment:** Interact with Regulatory Affairs, Clinical, Quality , Pharmacovigilance and Legal teams ... and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people...depend on - now and in the future. ROLE: Regulatory Intelligence Manager LOCATION: Fully Remote, East Coast is… more