- BeOne Medicines (San Mateo, CA)
- **General Description:** The Senior Director of Global Regulatory Project Management is a pivotal leadership role responsible for overseeing and driving the ... will have extensive experience leading a diverse team of regulatory project managers and cross-functional project...both internally and with external partners. + Collaborate with Regulatory Affairs, Clinical, CMC, Quality , Safety, and… more
- Abbott (Santa Clara, CA)
- …business units that Leveraged Services team supports. **The Opportunity** The **Associate Director Regulatory Affairs** will work for our Global Regulatory ... Administration (FDA) Center for Devices and Radiological Health (CDRH). This Associate Director Regulatory Affairs may analyze broad scope implications of… more
- Edwards Lifesciences (Irvine, CA)
- …we are supporting the needs and interests of the patients we serve. The Senior Director , Corporate & Regulatory Counsel role is a blend of subject matter legal ... expert and strong business acumen. The Senior Director , Corporate & Regulatory Counsel will have...legal guidance on the Company and TAVR business's commercial, regulatory , clinical and quality legal issues, this… more
- Ascendis Pharma (Palo Alto, CA)
- …Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director , Regulatory Affairs will serve as the therapeutic area head for ... the US RA Strategy team. This role involves managing regulatory submissions and providing strategic leadership to ensure the...as well as Life Cycle Management Strategies. The Sr. Director will work closely with the executive team to… more
- AbbVie (Irvine, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs Devices and Combination Products works with ... could impact initial product submissions, marketed products. Support AbbVie at Regulatory Authority/Notified Body project -specific meetings as well as industry… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …grow and become your best self. Become a **maker of possible** with us. The Sr. Director , Regulatory Affairs is the ranking Regulatory Affairs leader for the ... and teamwork skills + Current and comprehensive knowledge of global regulations and quality systems are required + Strong project coordination, business acumen… more
- BeOne Medicines (San Mateo, CA)
- … strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high- quality global submissions for investigational, market, ... product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for...for the assigned project . + Provide CMC regulatory review for clinical protocols and investigator brochures, etc.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …mitigation plans, and execute robust CMC regulatory strategies. + Leads CMC regulatory project teams and serves as core member of cross-functional PDM ... with life-threatening illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project (s), in line with ICH… more
- Gilead Sciences, Inc. (Foster City, CA)
- …or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional ... direct reports. + Provides matrix management and leadership to project teams. + Provides accurate and thorough input and...+ BA/BS with 10+ years' relevant experience. + Significant regulatory , quality , compliance or related experience in… more
- United Therapeutics (Sacramento, CA)
- …of biologic 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 ... experience with a Master's Degree in life sciences, quality , regulatory affairs or a related area...a related area of study + 8+ years of project or people management experience + Must have written… more
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