- Kyverna Therapeutics, Inc. (Emeryville, CA)
- …help transform how autoimmune diseases are treated.Kyverna is seeking an experienced and passionate Associate Director , CMC Regulatory Affairs with a ... preferably CAR T therapy. This position is responsible for providing Regulatory CMC strategies and leading the preparation of submissions and health authority… more
- Gilead Sciences, Inc. (Foster City, CA)
- Associate Director , Analytical Regulatory Sciences, Systems & Operations in CMC Regulatory AffairsJob DescriptionAt Gilead, we're creating a ... their aspirations. Join Gilead and help create possible, together.Job DescriptionThe Associate Director , Analytical Regulatory Science, collaborates with… more
- Ascendis Pharma A/S (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills.The Director , Regulatory Affairs will be responsible for developing and implementing ... global regulatory strategies encompassing clinical, non-clinical and CMC ...team (specifically from: Talent Acquisition Partner or Human Resources Director ) is not allowed. If this occurs your ownership… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** The Associate Director , Analytical Regulatory Science, collaborates with ... be accountable for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally.… more
- AbbVie (South San Francisco, CA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing ... + Participate in the planning/design, conduct, analysis, and interpretation of CMC studies and regulatory submissions. Participate in establishing departmental… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/ Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required + Ability to travel domestically… more
- Ascendis Pharma (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and ... implementing global regulatory strategies encompassing clinical, non-clinical and CMC ...team (specifically from: Talent Acquisition Partner or Human Resources Director ) is not allowed. If this occurs your ownership… more
- BeiGene (Emeryville, CA)
- **General Description:** The Associate Director , DP Commercial Small Molecule in External Supply Quality organization is responsible for ensuring the commercial ... cross functionally and collaboratively in BeiGene with eg Manufacturing, Supply Chain, Regulatory CMC and other Quality teams like QPs in EU. + Provide quality… more
- Gilead Sciences, Inc. (Foster City, CA)
- …more than 35 countries worldwide, with headquarters in Foster City, California. ** Associate Director - Material Science** **(Pivotal & Commercial Biologics)** ... as Pharmaceutical Development & Manufacturing (PDM), Quality, Supply Chain, Manufacturing, Regulatory Affairs CMC , Finance, and Technical Development throughout… more
