- Sumitomo Pharma (Lansing, MI)
- …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 (Lansing, MI)
- …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. (Lansing, MI)
- 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. (Lansing, MI)
- …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. (Lansing, MI)
- **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. (Lansing, MI)
- …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
- Otsuka America Pharmaceutical Inc. (Lansing, MI)
- …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 (Lansing, MI)
- …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
- State of Michigan (Kalamazoo, MI)
- …policies and procedures, DHHS rules and regulations, and accrediting and regulatory requirements. This position is primarily responsible for managing the release ... as the back-up in the absence of the department director . Position Description (https://MCSC.state.mi.us/AgencyPDFs/MDRCEXMEA61RPD2022.pdf) Job Specification To be considered… more