- Abbott (Plymouth, MN)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, ... Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly with FDA and other regulatory agencies. + Acts as… more
- AbbVie (North Chicago, IL)
- …and not on FDA promotional considerations. + Provides legal support to Regulatory Affairs on critical and strategic regulatory filings and agency engagements ... any combination of the above. + Individual will have substantial expertise in FDA regulations and guidance around innovator drug development, including on… more
- Sumitomo Pharma (Madison, WI)
- …a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, guidance ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory … more
- Rhythm Pharmaceuticals (Boston, MA)
- …experience in Regulatory Affairs Operations + Knowledge and understanding of the drug development process + Strong knowledge of FDA and Global EU/UK ... to overcome barriers, together. Opportunity Overview The Associate Director (AD) of Regulatory Operations is responsible for assisting the Head of Regulatory … more
- Chiesi (Cary, NC)
- …and rewarding work. Who we are looking for Purpose Responsible for the regulatory review and submission of advertising and promotional materials for all Chiesi ... to existing labeling, and submission of labeling information to regulatory authorities in the United States and Canada. Main...and by attendance of major FDLI, DIA and other industry/ FDA meetings. + Ensures that changes in US Prescribing… more
- Merck (Rahway, NJ)
- …quality and compliance across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, ... BS in biological sciences, chemistry, or related discipline with 10+ years of relevant drug development, clinical, or regulatory experience. + MS with 10+ years… more
- University of Southern California (Los Angeles, CA)
- …statutes, and laws, and with agencies including the IRB and Federal Drug Administration ( FDA ). Maintains compliance with Good Clinical Practice (GCP) ... Clinical Research Regulatory SpecialistApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/Clinical-Research- Regulatory -Specialist\_REQ20164101-1/apply) Keck School… more
- Lilly (Indianapolis, IN)
- …and updating approved global product registrations for drug substances and drug products. + Utilizes specialized scientific and regulatory expertise to ... documents. + Participates in health authority interactions reviewed by FDA assessment offices and other global regulators, as needed....knowledge in drug development including API, or Drug Product or Analytical + Demonstrated CMC regulatory… more
- Stryker (Mahwah, NJ)
- We are currently seeking a **Senior Manager, Regulatory Affairs** to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit). Ideally, ... FL with some workplace flexibility. As the **Senior Manager, Regulatory Affairs** , you will lead and coordinate global...maintained + Lead communications with health care authorities (eg FDA and EU Notified Bodies) and direct health authority… more