- Pfizer (Collegeville, PA)
- …responsible for developing and executing global (Influenza/COVID-19) and US (COVID-19) regulatory strategies and ensuring compliance with applicable regulations. ... Regulatory and Cross-functional teams, managing submissions, and interacting with Regulatory agencies worldwide (Influenza/COVID-19) or the US FDA (COVID-19).… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- …Work Instructions (WIs), and policies as needed, ensuring the department maintains compliance with current regulatory requirements and internal standards. + ... **Job Description Summary** Regulatory Affairs Coordinator II provides administrative support to the UCC Regulatory Affairs Team including as needed database… more
- Dentsply Sirona (Charlotte, NC)
- …to cross-functional teams throughout the product lifecycle + Reviews and interprets regulatory requirements and guidance documents to ensure compliance + ... drive innovation. **Make a difference** -by helping improve oral health worldwide. Sr. Regulatory Affairs Specialist + Leads regulatory submissions to obtain and… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Regulatory matters + Maintain good relationships with oncology and malignant hematology regulatory reviewers at FDA , EMA, and other key Health Authorities ... The role leads a group within Regeneron's Regulatory Affairs organization that provides guidance to Research,...are met within specified timelines and vital state of compliance is maintained. In addition, the position acts as… more
- Abbott (St. Paul, MN)
- …of blocked sales and distribution orders, providing guidance and direction on regulatory compliance . . Reviews and evaluates customer service requests and ... requirements. . Complies with US Food and Drug Administration ( FDA ) regulations, international regulations and other regulatory requirements, company… more
- Bausch Health (Bothell, WA)
- …and national/international standards. + Work together with Bausch Health Group PRC regulatory lead, ensuring regulatory compliance for Solta promotional ... requirements, as well as leadership and guidance on global regulatory strategy, such as US FDA product...on global regulatory strategy, such as US FDA product clearance, Health Canada registration, CE Marking, global… more
- Takeda Pharmaceuticals (Boston, MA)
- …of global cross-functional teams which require experienced interpretation of applicable EMA/ FDA /ICH/WHO/Global regulations to ensure CMC compliance within the ... GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. You will be RA CMC member on … more
- Sanofi Group (Morristown, NJ)
- …consistency between core and local market labeling; collaborate with regional /country regulatory teams to address labeling implementation or compliance issues. ... on organizational structure. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements ( FDA , EMA, ICH) and lifecycle labeling… more
- Kelly Services (Seattle, WA)
- …as **liquid handling robotics** and **DNA sequencers** . + Ensure compliance with regulatory agencies ( **GxP, FDA , ISO, GMP, GCP, GLP** ) and model ... of laboratory procedures and **explain technical information** effectively. + ** Regulatory responsibilities** in compliance with Good Clinical Practices… more
- Balchem (New Hampton, NY)
- …site. Follows GMP protocols, regulatory requirements, and works to ensure product compliance with regulatory bodies like FDA . + Develop an understanding ... and reports to communicate results to key stakeholders. + Understands regulatory requirements and works to ensure compliance . + Be able to travel up to 10-20% of… more
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