- GRAIL (Trenton, NJ)
- …position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements, pre-submissions, Premarket Approvals (PMAs), annual ... manage and provide direction to regulatory staff and, when required, participate in senior management meetings as a delegate. The role fosters a work culture aligned… more
- Bristol Myers Squibb (Princeton, NJ)
- …member of the Translational Medicine CLIA Laboratory Steering Committee, the director drives coordinated early-stage drug -diagnostic strategies and health ... paired with deep expertise in developing and executing global regulatory strategies across drug and device development. + Regulatory Standards Mastery, but not… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …(eg, PhRMA, EFPIA, JPMA, etc.). + Demonstrate solid working knowledge of the drug , biologic, and device development process, laws, regulations, and guidelines ... The Associate Director of Regulatory Intelligence leads the collection and...coordinate projects. + Demonstrates experience interacting with and supporting senior leadership. + Previous experience with people management and… more
- Organon & Co. (Jersey City, NJ)
- …modalities is preferred (eg, peptides, antibodies, gene or cell therapies, or drug - device combinations). + Extensive experience with review and authoring ... general medicines portfolio. The NCD team is comprised of non-clinical drug development scientists representing the disciplines of toxicology, DMPK, and… more
- Bausch Health (Bridgewater, NJ)
- …years practicing patent law (law firm experience preferred) in the medical device , chemical, and/or pharmaceutical field is required. + Demonstrated ability to think ... relating to, company personnel at all levels is required. Experience working with senior management/C-suite is preferred. The range of starting base pay for this… more