- BeOne Medicines (San Mateo, CA)
- …taken when recalls or product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for clinical protocols and ... regulatory strategies as well as authoring CTD CMC sections for the assigned project to...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and qualifications are as follows: **Responsibilities:** + Provides support for designated regional regulatory activities for PDM CMC Project and Commercial ... Teams, Regulatory Project and Regulatory Submissions Teams, with focus on Small/Synthetic Molecules. +...manager support. + Invests in acquiring knowledge about CMC regulatory intelligence including guidelines and … more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external...needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,… more
- BeOne Medicines (Emeryville, CA)
- …cost-effective production & continuity of supply + Partner with internal stakeholders such as CMC , Regulatory , Quality to ensure on time commercial launch & new ... **_General Description:_** Sr. Manager /Associate Director, Supply Chain CMO Management & PM...a scientific field. Minimum 10 years' experience within biopharmaceutical/pharmaceutical CMC development, GMP and regulatory requirements **Computer… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project Management partners to ... the care of patients with life-threatening diseases. The **Sr. Clinical Supply Manager ** is a leader that inspires teams while providing expertise for Gilead's… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Senior Director, Product Management Team Lead (Early Phase) will have experience serving as project manager for early phase biopharma molecules and will serve as ... **KEY RESPONSIBILITIES** Reporting to the Executive Director of Product & Project Management and operating within the broader Pharmaceutical Development and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Support or represent function and work collaboratively on cross-functional teams to support project team strategy and regulatory filings. . Fully embrace a ... documentation practices. . Author technical documents such as protocols, reports, regulatory dossier, etc. and prepare data-focused presentations for internal and… more