- Ascendis Pharma (Palo Alto, CA)
- …the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr . Director , Regulatory Affairs will serve as the ... trials as well as Life Cycle Management Strategies. The Sr . Director will work closely with the...devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …to learn, grow and become your best self. Become a **maker of possible** with us. The Sr . Director , Regulatory Affairs is the ranking Regulatory ... with RA business partners, provides input into the budget process for Regulatory Affairs + Represents the Platform in interactions/negotiations with global… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the submission preparation process in close partnership with other functions in PDM, Regulatory Affairs , and Clinical Development. + Exercises expertise in the ... degree with directly relevant professional experience in biologics product development, global CMC regulatory affairs , and CMC technical areas of at least 14… more
- United Therapeutics (Sacramento, CA)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of...Ability to mentor, coach, guide, and train lower to senior level employees **Preferred Qualifications** + Proficient knowledge of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs , and affiliates on internal meetings and leads global ... draft regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior...Bachelor's degree and 12+ years of experience in CMC Regulatory Affairs (CMC RA) or other relevant… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual ... in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC-related regulatory submissions and… more
- Stryker (San Jose, CA)
- **Key Areas of Responsibility:** + Ensure divisional achievement of quality, regulatory , and compliance targets + Direct activities to ensure new product development ... and product sustainment meet regulatory requirements + Develop, lead, and execute a regulatory strategy ensuring that it is appropriate and effective in meeting… more
- Danaher Corporation (Sunnyvale, CA)
- …to complicated assay, instrument, software projects and/or system projects. This position reports to the Sr . Director Regulatory Affairs , NPD and is part ... Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Regulatory Affairs Principal is responsible for serving… more
- Sumitomo Pharma (Sacramento, CA)
- …Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as ... position of ** Director , ...eg Marketing and their Agencies, Legal, Compliance, and Medical Affairs . + Provide appropriate oversight of promotional material review… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** The Senior Director , Medical Education & Programs is a global role that ... team, fostering an environment of innovation and outcomes. In this role, the Senior Director will collaborate with cross-functional teams (eg Legal, Compliance,… more