- GRAIL (Santa Fe, NM)
- …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 (Santa Fe, NM)
- …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. (Santa Fe, NM)
- 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. (Santa Fe, NM)
- 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. (Santa Fe, NM)
- …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. (Santa Fe, NM)
- **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
- Otsuka America Pharmaceutical Inc. (Santa Fe, NM)
- **Job Summary** The Associate Director , Quality Operations will lead initiatives that drive operational excellence, enhance risk management practices, and ... leader within a matrixed organization. + Collaborate with Supply Chain, Regulatory Affairs , IT, and other functions to ensure integrated quality operations. +… more
- Otsuka America Pharmaceutical Inc. (Santa Fe, NM)
- 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
- Otsuka America Pharmaceutical Inc. (Santa Fe, NM)
- …compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product ... all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. + Collaborate with global… more
- Otsuka America Pharmaceutical Inc. (Santa Fe, NM)
- …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. (Santa Fe, NM)
- …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 (Santa Fe, NM)
- …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
