- Boehringer Ingelheim (Athens, GA)
- …Director, US Regulatory Affairs Pharmaceuticals is a key interface with US Regulatory Authorities such as the FDA & EPA and drives regulatory ... Ingelheim's high regard for our employees. The Director, US Regulatory Affairs Pharmaceuticals leads the US ...for all new product types and entities licensed via FDA -CVM & EPA and as well as Life Cycle… more
- Fujifilm (Bothell, WA)
- … regulatory compliance and global submission processes, including labelling, clinical affairs , new product development, international regulatory ... **Position Overview** The Regulatory Affairs Associate requires application of...and development or documentation of procedures + Familiarity with FDA regulations and major international market such as Canada,… more
- System One (Florham Park, NJ)
- Job Title: AD or Director, Regulatory Affairs Strategy Location: Florham Park, NJ (10 days onsite per month) Type: 12-month contract Must haves: + Must be local ... in IND/NDA development, not just life cycle management. Overview Support the Regulatory Affairs (Executive Director) in developing and executing regulatory… more
- Nestle (Chicago, IL)
- …for patients and consumers. **Position Summary:** Reporting to the Head of Global Regulatory Affairs Pharma, the Regulatory Affairs Advertising, ... ensuring alignment with the overall company strategy. In collaboration with Global Regulatory Affairs leads and cross functional teams, this individual will… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Gilead and help create possible, together. **Job Description** As an Associate Director, Global Regulatory Affairs , you will act as the Regional Regulatory ... or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. Position will be filled...+ In-depth understanding of US Food & Drug Administration ( FDA ) and European Medicines Agency (EMA) regulatory … more
- Danaher Corporation (Miami, FL)
- …possess previous experience in: . Prior internship or coursework in regulatory affairs or quality assurance . Understanding of FDA , EMA, or ICH guidelines ... the Danaher Business System which makes everything possible. The Regulatory Affairs Intern will gain hands-on experienc.... Collaborate with cross-functional teams including R&D, Quality, and Clinical Affairs . Help ensure compliance with… more
- Abbott (Plymouth, MN)
- …with their lives. **The Opportunity** Abbott is seeking a passionate, experienced **Senior Regulatory Affairs Specialist** to join our team on-site in Plymouth, ... affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly with FDA and other regulatory… more
- Stryker (Redmond, WA)
- We are currently seeking a **Senior Regulatory Affairs Specialist** to join our **Medical** **Division** to be based **Hybrid** in **Redmond, Washington.** As ... part of the Medical Regulatory Affairs team, you will work with...appropriate communication tools. + Evaluate proposed pre- clinical , clinical , and manufacturing changes for regulatory filing… more
- Sumitomo Pharma (Lincoln, NE)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Global Regulatory Affairs (GRA) team based in the...to achieve results + Understanding of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical… more
- Abbott (Alameda, CA)
- …**The Opportunity** Lingo is seeking an impactful Global Head of Quality and Regulatory Affairs to lead our innovative biowearables initiative and drive the ... Countries, and Asia. Overseeing all aspects of quality and regulatory affairs , from design and development to...or connected health solutions. + Extensive knowledge of global regulatory requirements, including FDA regulations (eg, 21… more