- Abbott (Santa Clara, CA)
- … regulatory review. + Monitor and submit applicable reports to regulatory authorities. + Evaluate proposed preclinical, clinical and manufacturing changes ... and software, vessel closure devices and peripheral stents. This **Principal Regulatory Affairs Specialist** position is an onsite opportunity working out of… more
- Oura (San Francisco, CA)
- …data applications, and health and wellness claims. + Provide legal and regulatory oversight for clinical studies and evidence generation, including IRB ... regulatory guidance and guide teams on risk-based approaches to regulatory compliance in product development, clinical validation, and market positioning.… more
- BeOne Medicines (San Mateo, CA)
- …complaints arise during product lifecycle for the assigned project. + Provide CMC regulatory review for clinical protocols and investigator brochures, etc. for ... **_General Description:_** BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent… more
- Abbott (Pleasanton, CA)
- …mindset. Success in this role requires close partnership with product, clinical , regulatory , quality, compliance, security, and engineering teams within ... adherence to best practices. + Collaborate closely with product management, clinical teams, regulatory , quality, compliance, security, and engineering leaders… more
- BeOne Medicines (San Carlos, CA)
- …of the job:** + Lead quantitative assessments of pipeline molecules, integrating clinical , commercial, and regulatory factors to evaluate potential success. + ... assets. + Develop valuation models for pipeline molecules, integrating scientific, clinical , regulatory , and market access considerations. + Support strategic… more
- BeOne Medicines (San Mateo, CA)
- …our dynamic team. The ideal candidate will have a strong background in research, clinical development, regulatory affairs, and safety, with a particular focus on ... strategy for the R&D department** , aligning technology initiatives with research, clinical development, regulatory , and safety goals. + **Drive innovation in… more
- Edwards Lifesciences (Irvine, CA)
- …unmet needs, overcome market access barriers, and drive impactful evidence for clinical , regulatory , and commercial success. This role also includes direct ... datasets and deliver insights. + Engage and partner with physicians and clinical experts to develop high-quality clinical papers, abstracts, and presentations,… more
- IQVIA (San Francisco, CA)
- …of development from discovery to market. You will oversee preclinical strategy, clinical strategy, regulatory strategy, and commercial strategy, and assess the ... for various clients. + Provide strategic and therapeutic area guidance for clinical development plans in compliance with applicable regulatory , medical, and… more
- Merck (Sacramento, CA)
- …efficacy and safety. + Skill in authoring and reviewing imaging documents for clinical trials. + Regulatory experience supporting drug filings. Current Employees ... Description** **of** **Position** The Imaging Lead (Sr. Principal Scientist) works with Clinical Imaging Scientists to support clinical trial teams in the… more
- Bristol Myers Squibb (San Diego, CA)
- …study-related information. This role will work cross-functionally with several departments ( Clinical Operations, CMC, Regulatory Affairs, Supply Chain, Drug ... functional team members both within medical affairs as well as clinical development, clinical operations, regulatory , legal, etc + Collaborate with… more