- Gilead Sciences, Inc. (Foster City, CA)
- … Information Management system. **Qualifications** + Bachelor's degree and 12+ years of experience in CMC Regulatory Affairs ( CMC RA) or other relevant ... guidances, and communicates changes in regulatory CMC information to project teams and senior ... guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs… more
- BeOne Medicines (San Mateo, CA)
- …including BeOne's Senior Management. This role blends deep expertise in regulatory affairs with best-in-class project management skills to ensure timely, ... **General Description:** The Senior Director of Global Regulatory Project...both internally and with external partners. + Collaborate with Regulatory Affairs , Clinical, CMC , Quality,… more
- Ascendis Pharma (Palo Alto, CA)
- …United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr . Director, Regulatory Affairs will serve as the therapeutic ... trials as well as Life Cycle Management Strategies. The Sr . Director will work closely with the executive team...devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in… more
- Cardinal Health (Sacramento, CA)
- **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations provides regulatory affairs and product ... submissions within the discipline of chemistry, manufacturing, and controls ( CMC ). The _Sr. Coordinator, Regulatory Submissions Operations_ will use… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
- AbbVie (San Francisco, CA)
- …of Drug Development (eg, pre-clinical research, clinical development, Regulatory Affairs , Chemistry Manufacturing and Controls ( CMC )). + Experience with ... assessments of individual partnering opportunities to therapeutic area leadership and senior governance committees as well as contributing to Specialty and Discovery… more
- AbbVie (Irvine, CA)
- …required by program needs, in partnership with Discovery, Translational, and CMC colleagues contribute to design and implement translational strategies. May ... opinion leader interactions related to the disease area(s); partners with Medical Affairs , Commercial and other functions in these activities as required, consistent… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- BeOne Medicines (Emeryville, CA)
- …**job:** Accountable and responsible for building and maintaining relationships within Regulatory Affairs and functional organizations including partnering with ... as CMC , Reg Strategy, Clinical/Non-Clinical, Quality/Manufacturing, GTS, Pharmacovigilance and Regulatory Compliance. This position will also play a key role in… more