- Philips (San Diego, CA)
- … agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications. + Regulatory Affairs representative for ... and marketing strategy. **Your role:** + The Senior RA Specialist provides the regulatory plan, guidance on...product reports. Reviews and recommends changes for labeling, and clinical protocols to maintain regulatory compliance. Keeps… more
- Actalent (Carlsbad, CA)
- Description: The Sr. Regulatory Affairs Specialist - Europe participates and manages necessary regulatory and project management activities required for ... thinking, and collaboration with others. Plan and prepare global regulatory dossiers with a focus on Medical Device Technical...well, what strategies work to get submittions, + Some clinical experience/knowledge - report out this data + No… more
- Philips (San Diego, CA)
- …demonstrate a track record in obtaining FDA clearances and/or worldwide registrations, clinical trials and software development/ regulatory submissions is a ... role you have the opportunity to** Responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory … more
- Pfizer (San Diego County, CA)
- …management of external and internal partners involved in the implementation of clinical trial biomarkers sample analyses. **ROLE RESPONSIBILITIES** + Provide ... support for selection, qualification, and periodic audits of CRO laboratories supporting clinical trial biomarker assays. + Coordinate with Study Teams and… more
- ThermoFisher Scientific (San Diego, CA)
- …a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of ... research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver... clinical research services provide end-to-end support for clinical trials from study start up to… more
- Bristol Myers Squibb (San Diego, CA)
- …access to clinical trials . + Leads major evidence read-outs with clinical trial investigators eg, Ph 3 top-line data. + Support Interventional and ... regulatory guidelines **Understanding of scientific publications** + Clinical trial design and process + Understanding...unique perspectives in an inclusive culture, promoting diversity in clinical trials , while our shared values of… more