- Gilead Sciences, Inc. (Parsippany, NJ)
- … Affairs, Precision Medicine, you will help develop and execute Precision Medicine regulatory strategy in alignment with the drug global regulatory ... more
- UPMC (Pittsburgh, PA)
- …Drug Administration (FDA) is essential OR 1+ year's of experience in drug development, regulatory or clinical operations functions is preferred. + Exceptional ... more
- Takeda Pharmaceuticals (Boston, MA)
- …plans effectively accommodate appropriate precision medicine approaches by effectively integrating drug and diagnostic regulatory and submission plans including ... more
- Lilly (Indianapolis, IN)
- …effecting change in regulatory policies that advance patient outcomes, reduce regulatory risk, and improve efficiency in drug development. The purpose of ... more
- Amgen (Washington, DC)
- … mechanisms to optimize product development (eg, expediting studies, Orphan Drug Designations, expedited regulatory designations, compassionate use, and ... more
- Gilead Sciences, Inc. (Foster City, CA)
- …Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet ... more
- Pfizer (Cambridge, MA)
- …reviewing and managing analytical characterization sections for antibodies and antibody drug conjugates for regulatory filings; Performing and managing extended ... more
- Lilly (Indianapolis, IN)
- …scientific degree (ie, PhD, PharmD) and 8+ years Industry-related experience in regulatory affairs and/or drug development experience OR + Bachelor's with ... more
- Takeda Pharmaceuticals (Lexington, MA)
- …FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. + Provide regulatory strategic oversight ... more
- J&J Family of Companies (Raritan, NJ)
- …in regulatory affairs is preferred. + Solid understanding of the drug development process and regulatory submission and approval processes is required. ... more
- Takeda Pharmaceuticals (Boston, MA)
- …experience. + Preferred experience in reviewing, authoring, or managing components of regulatory submissions. + Solid working knowledge of drug development ... more
- Takeda Pharmaceuticals (Boston, MA)
- …experience. + Preferred experience in reviewing, authoring, or managing components of regulatory submissions. + Solid working knowledge of drug development ... more
- Sanofi Group (Morristown, NJ)
- …as the future life cycle management of switch line extension opportunities including regulatory classes ( drug , medical device, combination products). + Lead the ... more
- Kelly Services (Valencia, CA)
- …regulatory affairs + Knowledge of FDA medical devices and/or pharmaceutical ( drug ) registrations. + Familiarity with regulatory submissions and performing ... more
- Takeda Pharmaceuticals (Boston, MA)
- …pharmacometrics and regulatory guidance documents. + Sound knowledge of drug regulatory authority biopharmaceutics and clinical pharmacology requirements to ... more
- MAAC (Metropolitan Area Advisory Committee) (Chula Vista, CA)
- …hours and/or units (CEH or CEU) as determined by the Department of Alcohol and Drug Programs and/or other regulatory agencies. + Performs other related duties as ... more
- Lilly (Indianapolis, IN)
- …and updating approved global product registrations for drug substances and drug products. + Utilizes specialized scientific and regulatory expertise to ... more
- Boehringer Ingelheim (Ridgefield, CT)
- …Specialty Care/ Rare Disease pharmaceutical products. + Experience in FDA prescription drug regulatory matters including experience in the federal Anti-Kickback ... more
- Lilly (Indianapolis, IN)
- … drug /device clinical development and knowledgefromhealth authorities such as regulatory policies, regulatory precedents, trends, and emerging regulatory ... more
- Bausch Health (Bridgewater, NJ)
- …committees and appropriate other Company staff regarding changes in the current regulatory environment at FDA's Office of Prescription Drug promotion (OPDP) ... more