- Eisai, Inc (Baltimore, MD)
- …budgeting, vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with ... difference. If this is your profile, we want to hear from you. The Associate Director of Global Submission Management (GSM) is responsible for leading, managing,… more
- Sumitomo Pharma (Annapolis, MD)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The ... Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily function as a regional regulatory leader… more
- GRAIL (Annapolis, MD)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to ... + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and strengthen and… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- The Associate Director , Congress and Medical Education Strategy & Execution is responsible for executing and contributing to the global medical strategy and ... patient outcomes through deep scientific understanding and collaborative partnerships. The Associate Director partners closely with global and regional… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …needs and nutraceutical products for the maintenance of everyday health. As an Associate Director , Biostatistician, you will be a champion of Otsuka's culture ... statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues,… more
- Guidehouse (Hanover, MD)
- …Software, Assay chemistry, microbiology, virology, immunology **_Programmatic/Technical Advisor_** - Associate Director + **Doctoral degree** in biological ... FDA/ICH guidelines and CDISC data standards + Experience in pharmaceutical industry regulatory affairs and/or quality assurance and/or quality control + Direct… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …to address strategic objectives to business partners. + Work closely with medical affairs , marketing, and IT teams to ensure alignment and integration of omnichannel ... Research, Analytics, Otsuka Information Technology (OIT), Sales Operations, and Medical/ Regulatory /Legal integrated business partners. **Minimum Qualification:** + Bachelor's degree… more
- Johns Hopkins University (Baltimore, MD)
- …A minimum of 10 years of relevant experience in educational program compliance, legal/ regulatory affairs , or related roles within a higher education or ... Executive Director of Educational Program Compliance, JHUSOM Compliance Office...is also responsible for monitoring the evolving legal and regulatory enforcement landscape under all applicable laws and regulations.… more
- University of Washington (Annapolis, MD)
- …positive outlook and calm demeanor, and to work independently, especially during times when the Director and Associate Director are away from the office for ... **Job Description** **We have an outstanding opportunity for an Assistant to the Director to serve as the first point-of-contact in the DC-based Office of Federal… more
- University of Maryland, Baltimore (Baltimore, MD)
- …in the MS in Regulatory Science program, with a focus on introductory and regulatory affairs aspects of the program, as well as another aspect of the program ... AREAS OF EXPERTISE AND EXPERIENCE_* Regulatory science, including introductory and regulatory affairs aspects, as well deep knowledge in another aspect (eg… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …internal and external regulations. This position reports directly to the Associate Director , CNS Scientific Communications. **Job Description** **Key ... Include:** **Core Content Development** + Under the guidance of the Associate Director , Medical Communications, draft and maintain high-priority, foundational… more
- Sumitomo Pharma (Annapolis, MD)
- …Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director , Clinical Business Operations, the specialist ensures accountable ... system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as… more
