- 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
- 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
- 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
- United Therapeutics (Annapolis, MD)
- …that UT data is approved and ready for field use following presentation. Associate Medical Excellence & Training Director Minimum Requirements + Bachelor's ... (slides, FAQ, talking points etc.) + Partner with Global Medical Affairs /product development, and global partners' subject matter experts to develop/execute disease… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- The Associate Director , Scientific Communications manages the execution of the core scientific and medical communications strategy for the relevant therapeutic ... accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs ,… 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
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- **Job Summary** The Associate Director , Global Product Quality - GMP Process is responsible for enabling the optimization and harmonization of key GMP quality ... alignment with corporate quality objectives + Cross-functional Leadership:Collaborate with Regulatory Affairs , Technical Operations, Manufacturing, and Supply… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- **Job Summary** The Associate Director , R&D HCP Engagement CoE is a critical change agent and system implementer responsible for designing the operating model ... to a direct report responsible for day-to-day execution. While initially focusing on Medical Affairs , the vision is to cover all R&D HCP engagement over time. This… 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)
- The Associate Director of Global Supplier Quality will be responsible for the execution of supplier quality audit and monitoring across the company's global ... outcomes. + **Cross-Functional Collaboration** + Collaborate with Procurement, Manufacturing, Regulatory Affairs , and Technical Operations to ensure supplier… more
