- GRAIL (Menlo Park, CA)
- …to project teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as ... For more information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with key internal… more
- United Therapeutics (Sacramento, CA)
- …like lungs, pancreases and hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory pathways, managing documentation and ... timelines, and supporting the preparation and execution of regulatory submissions for our whole organ tissue engineering program. Are you looking to fundamentally… more
- Gilead Sciences, Inc. (Foster City, CA)
- … guidances, comments on draft regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior management. + Provides ... illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with ICH requirements,… more
- BeOne Medicines (San Mateo, CA)
- **_General Description:_** BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent ... responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA interactions to meet the aggressive timelines… more
- Genentech (South San Francisco, CA)
- …resolution of program and disease-specific technical challenges.** **The Opportunity:** **The Director /Sr. Director Project Team Leader (PTL) leads projects and ... Early Clinical Development, Development Sciences, Translational Medicine, Commercial, Finance, Regulatory , Manufacturing) to define project vision, strategy, product evaluation,… more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Director , Senior Corporate Counsel Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology ... seasoned and highly motivated transactional attorney to serve as Senior Director , Senior Corporate Counsel...help resolve critical legal and business issues arising from regulatory , research and development, IT and clinical activities. *… more
- Amentum (Sacramento, CA)
- Senior Director of Operations, Integrated Facility Management, with experience working in Life Sciences. Strategic leader responsible for ensuring efficient, ... funds and property, and representing the company with respect to the client. The Senior Director of Operations oversees a workforce of Regional and Site… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director , GCD is responsible ... support of domestic and international clinical development initiatives. The Senior Director , GCD works in a multidisciplinary...develop the drug in accordance with a clinical and regulatory strategy. + Working with experts and consultants in… more
- AAA Northern California, Nevada & Utah (Walnut Creek, CA)
- …life by unleashing the innovative spirit of our Team Members. JOB SUMMARY The Senior Director of Insurance Operations Management is responsible for all facets of ... strategies, policies, and programs that support organizational goals and regulatory requirements + Manage relationships with stakeholders including negotiating… more
- Genentech (South San Francisco, CA)
- …part of a thriving culture built on collaboration and innovation. Job Summary The Senior Director , Therapeutic Area Analytics & Insights - Rare Diseases (RD) at ... and Business Development. As a key advisor to the Senior Leaders, the Senior Director ...with the diagnostic challenges, patient advocacy landscape, and evolving regulatory pathways for rare disease therapies. + Proven track… more
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