- BeOne Medicines (Emeryville, CA)
- …with the FDA and Health Canada as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals ... **General Description:** The Director, Regulatory Affairs will be responsible for developing, implementing,...both small molecules and biologics + Thorough understanding of drug development process and the pharmaceutical industry and healthcare… more
- BeOne Medicines (San Mateo, CA)
- …with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite ... **General Description** **_:_** + The Director, Global Regulatory Lead, will be responsible for developing, implementing, and advising on global regulatory … more
- Parexel (Sacramento, CA)
- …and/or drug -device combination products are a plus) * Support regulatory leads in developing contingency plans for CMC-related scenarios * Represent CMC ... FDA, EMA, and Health Canada (IND, NDA, DMF) * In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet ... analysis and reporting of Gilead clinical data in efficiently achieving regulatory , scientific and business objectives. The Director will be primarily responsible… more
- Bristol Myers Squibb (San Diego, CA)
- …clinical development leader; with greater than 10 years of extensive clinical trial, drug development, and regulatory experience, in addition to a strong ... organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution,… more
- Bristol Myers Squibb (Brisbane, CA)
- … Development leader; with greater than 5 years of extensive clinical trial and drug development experience and regulatory experience, in addition to a strong ... and oversight for one or more clinical trials within the Global Drug Development organization. This position will provide the candidate an opportunity to… more
- Pfizer (South San Francisco, CA)
- …Experience in pharmacometric analyses + Good communication skills (written, oral). + Drug development and/or regulatory experience + Publications in relevant ... ideas, and recognizes individual contribution. **ROLE SUMMARY:** + Develops model informed drug development (MIDD) plans across projects and disease areas in order… more
- Bristol Myers Squibb (Brisbane, CA)
- …data analysis, interpretation, and reporting + Collaborates on cross-functional drug development teams, regulatory submissions, and departmental initiatives; ... The Director will play an active role in our drug discovery and development efforts to advance RayzeBio's (a...drug development (MIDD) approaches + Track record of regulatory interactions and deliverables, eg, IND, NDA, BLA and… more
- Pfizer (South San Francisco, CA)
- …and programming software (eg, Nonmem, R). + Experience in pharmacometric analyses + Drug development and/or regulatory experience + We encourage applicants from ... ideas, and recognizes individual contribution. **ROLE SUMMARY:** + Develops model informed drug development (MIDD) plans across projects and disease areas in order… more
- Lilly (San Francisco, CA)
- … drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug product development and manufacturing ... people around the world. **Job Summary** The Director/Senior Director, CMC, Drug Product Development will lead formulation development activities across multiple… more