- Sumitomo Pharma (Albany, NY)
- …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 (RRL) and/or Global ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Capital One (New York, NY)
- Director , International Regulatory Affairs Advisor...a great place to work. Within Capital One, the Regulatory Affairs function is a global ... to work in close partnership with the Vice President for International Regulatory Affairs , to architect and operationalize an enterprise-wide program designed… more
- GRAIL (Albany, NY)
- …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
- Regeneron Pharmaceuticals (Troy, NY)
- …the Health Authority. **A typical day might include:** + Oversee the assigned CMC/CP Regulatory Affairs team, driving global regulatory strategies and ... team. The candidate will be responsible for the development and execution of global regulatory strategies for the assigned drug/device portfolio. This role… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- The Senior Director of Regulatory Intelligence will lead global regulatory intelligence activities and partner with other members of the Regulatory ... and guidance + Support business stakeholders in driving strategies for compliance with global regulatory requirements + Oversee the review of regulatory … more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …business development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory ... Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …documents, including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. ... on the large global clinical trials and regulatory filing activities. The Senior Director , GCD...trial implementation and management. + Complete understanding of the global regulatory requirements. + Working knowledge of… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …compliance and operational efficiency. + GMP Compliance: Ensure all quality processes meet global regulatory requirements (eg, FDA, EMA, PMDA) and align with ... The Director , Global Product Quality, GMP Processes...+ Cross-Functional Collaboration: Partner with regional quality leaders, manufacturing, regulatory affairs , and technical operations to ensure… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …governance practices. **Compliance & Governance** + Ensure quality operations comply with global regulatory requirements (eg, FDA, EMA, PMDA) and internal ... **Job Summary** The Associate Director , Quality Operations will lead initiatives that drive...within a matrixed organization. + Collaborate with Supply Chain, Regulatory Affairs , IT, and other functions to… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …for assigned compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned ... activities related to all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.… more