- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead is responsible for ... with colleagues across the global RA CMC organization, Gilead regulatory affairs , and affiliates on internal meetings and Health Authority interactions.… more
- Ascendis Pharma (Palo Alto, CA)
- …we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic area head for assigned ... devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in...the pharmaceutical or biotechnology industry with focus on biologics, small molecules , or synthetic peptides + Strong… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and ... Provide CMC regulatory strategy input and expertise in the area...the area of investigational, new and marketed biologic and small molecule drug products to assigned project teams, to… more
- BeOne Medicines (Emeryville, CA)
- …or more major geographic areas, and prior experience with both small molecules and biologics. Has sufficient regulatory knowledge to integrate inputs from ... are met while leveraging expedited pathways where appropriate. The individual has regulatory affairs departmental and cross functional influence and acts as… more
- Gilead Sciences, Inc. (Foster City, CA)
- …development to commercialization for all modalities. With Gilead's diverse portfolio, including small molecules , peptides, and biologics, this leader will have ... pioneer to develop a strategic vision to seamlessly bring small molecules and large molecules ...with Gilead PDM functions such as Quality Assurance, CMC Regulatory Affairs , Manufacturing and Technical Operations, Product… more