- Gilead Sciences, Inc. (Foster City, CA)
- …& Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical Development to ... as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. +...and drug product. + Proven track record in drafting regulatory documentation at all stages, including **IND, BLA, and… more
- Danaher Corporation (Sunnyvale, CA)
- …with core team stakeholders such as Project Management, Portfolio Management, R&D, Quality, Regulatory , and Clinical Affairs . The essential requirements of ... years of this type of experience + Demonstrated experience of translating clinical value into marketing messages across lab, clinical /healthcare provider, health… more
- AbbVie (Irvine, CA)
- …The individual will partner with other skincare R&D functions- skincare biological research, clinical , regulatory , safety and scientific affairs to create ... future pipeline and support current marketed products. The individual will oversee the buildout, management and execution of the Skincare Aesthetics Bioprocessing Innovation Center in the development of new cosmetic ingredient technologies. The position will… more
- Merck (San Diego, CA)
- …+ Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams. + Provide ... brochures + Local registration study protocols for secondary markets + Represent Global Regulatory Affairs on internal committees (eg, DRC, ADT/PDT, EDT, LEAD)… more
- Stanford University (Stanford, CA)
- …impact. We are looking for someone who already has a strong foundation in regulatory affairs and human subjects research, and/or specialized knowledge of working ... regulatory experts responsible for the administration and regulatory compliance of clinical research within the...required, but some previous coursework or prior jobs in regulatory affairs is expected. This position can… more
- Cedars-Sinai (Beverly Hills, CA)
- …+ This role requires a strong background in Regulatory Sciences, Regulatory Affairs , and/or Clinical Research, with demonstrated experience navigating ... and enhancements to keep on track with new regulations/compliance policies in clinical and regulatory sciences. **Qualifications** **This role follows a hybrid… more
- BeOne Medicines (San Mateo, CA)
- …are met while leveraging expedited pathways where appropriate. The individual has regulatory affairs departmental and cross functional influence and acts as ... leadership on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical...candidates will have experience working as a lead in Regulatory Affairs across two or more major… more
- J&J Family of Companies (Irvine, CA)
- …when applicable manage submissions to the Notified Body. + Partner with R&D, Medical Affairs , Clinical , and Regulatory in the establishment of appropriate ... more at https://www.jnj.com **Job Function:** R&D Operations **Job Sub** **Function:** Clinical Trial Support **Job Category:** People Leader **All Job Posting… 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 ... the Regulatory reviewer for assigned products. This position is responsible...strategies to optimize the commercial success of products for clinical trials, labeling, etc. + Develop and maintain productive… more
- J&J Family of Companies (Irvine, CA)
- … R&D partners and cross-functional partners (eg Global Strategic Marketing, Medical Affairs , Regulatory Affairs , Health Economics and Market Access, ... assigned project budgets to ensure adherence to business plans; . Supports clinical scientific discussions with regulatory agencies/ notified bodies to drive… more