- United Therapeutics (Research Triangle Park, NC)
- …of preclinical studies to ensure the successful submission and approval of a drug product by regulatory agencies. This role will provide scientific insight ... an option. **Who you are** We are seeking a highly motivated Clinical Drug Development Scientist to join our team. You will support the design, implementation,… more
- University of Maryland, Baltimore (Baltimore, MD)
- …regulatory agency site visits. This program covers all major areas of drug product and biologics regulatory science, including: Chemistry, Manufacturing, and ... fulfill the faculty position of Instructor (non-tenure track) for the MS in Regulatory Science within the Department of Pharmaceutical Sciences. The MS in … more
- Takeda Pharmaceuticals (Boston, MA)
- …ensure the integrity, compliance, and oversight of data related to the drug development lifecycle, including regulatory submissions, labeling, and product ... of regulatory updates on data, coordinating with regulatory teams (eg, submission publishing, CMC, drug ...with regulatory teams (eg, submission publishing, CMC, drug labeling, compliance, and IT) to achieve aligned and… more
- Kelly Services (Valencia, CA)
- …regulatory affairs + Knowledge of FDA medical devices and/or pharmaceutical ( drug ) registrations. + Familiarity with regulatory submissions and performing ... ** Regulatory Affairs Specialist - Valencia, CA** Kelly(R) Science...Valencia, CA** Kelly(R) Science & Clinical is seeking a Regulatory Specialist for a temporary, long-term position (approx. 1… more
- Takeda Pharmaceuticals (Boston, MA)
- …experience. + Preferred experience in reviewing, authoring, or managing components of regulatory submissions. + Solid working knowledge of drug development ... to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global … more
- Takeda Pharmaceuticals (Boston, MA)
- …related experience. + Experience in reviewing, authoring, or managing components of regulatory submissions. + Expert knowledge of drug development process and ... + Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple… more
- Boehringer Ingelheim (Ridgefield, CT)
- …DNP, DO, Ph.D., Master's) preferred + Specialized Pharmacist or Master of Drug Regulatory Affairs, RAC certification preferred **Associate Director Experience ... the global and US cross-functional teams. They will also provide US strategic regulatory guidance to facilitate efficient and compliant drug development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …pharmacometrics and regulatory guidance documents. + Sound knowledge of drug regulatory authority biopharmaceutics and clinical pharmacology requirements to ... analysis tools. + Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements and PK/PD analysis. +… more
- Wolters Kluwer (Philadelphia, PA)
- …and tracking success metrics. * Leverage knowledge of US healthcare government and regulatory published drug information and policy data sources (CMS, FDA, etc.) ... **Lead Technology Product Manager** - Commercial Drug Information This role follows a hybrid model,...drug clinical attributes, pricing and reimbursement data, and regulatory classifications-and how these data types are used in… more
- Bristol Myers Squibb (Princeton, NJ)
- …studies including FIH, and strategies in 14C human ADME studies. + Understanding of regulatory requirements in the areas of drug metabolism, drug - drug ... areas: + Experience in drug development, authoring drug metabolism reports for regulatory submissions. +... development, authoring drug metabolism reports for regulatory submissions. + In-depth understanding of the principles, theories… more