- AbbVie (South San Francisco, CA)
- …peptide drug substance and drug product development. + Experience developing global regulatory strategies including authoring regulatory submissions , and ... to execute and deliver material and information for clinical trials and regulatory submissions . + The candidate will identify and nurture ideas for continuous… more
- Abbott (Santa Clara, CA)
- …scientific data and staying abreast of current clinical practice. + Facilitates regulatory submissions and communications by communicating with Regulatory ... use scientific and medical knowledge to write strategic responses to questions from regulatory bodies about submissions . + Participates in the development of… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …collection, storage conditions, and analytical testing, to support product development and regulatory submissions . + Author and review INDs, NDAs, and other ... regulatory submissions , ensuring accuracy, completeness, and adherence to regulatory requirements. + Perform holistic analysis of the analytical projects… more
- BeOne Medicines (Emeryville, CA)
- …robust study design, insightful data analysis, and timely support for global regulatory submissions . Deep expertise in PK modeling, including non-compartmental ... . Ensure high-quality, compliant, and timely delivery of statistical components for regulatory submissions (eg, INDs, NDAs, BLAs, and global equivalents). .… more
- AbbVie (Irvine, CA)
- …expert, author, edit and review key section of research protocols, reports and regulatory submissions . Responsibilities: + Based on strong medical and scientific ... protocols, Investigator Brochures, Clinical Study Reports, Clinician Reported Outcome Dossiers, regulatory submissions and responses and other program documents.… more
- BeOne Medicines (San Carlos, CA)
- …to enhance biomarker discovery and development efforts. + Contribute to regulatory submissions related to biomarker strategies and companion diagnostics. ... medicine, with a track record of successful biomarker strategies leading to regulatory submissions , approvals, or high-impact publications. + Experience managing… more
- Terumo Neuro (Aliso Viejo, CA)
- …with the clinical & regulatory teams to write clinical documents for regulatory submissions , including but not limited to: + Clinical evaluation reports + ... years of scientific experience. 3. Demonstrated experience in the development of regulatory / clinical submissions (preferably as a medical writer for… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …through experimental design and execution. + Oversee technical documentation, regulatory submissions , and alignment with commercial product lifecycle. ... and fluorophore-based detection. + Experience in analytical method validation for regulatory submissions (IND, BLA). + Solid grasp of cGMP and regulatory… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Regulatory Affairs requirements, regulations and standards + Experience authoring regulatory submissions (US and Global) + Strong prioritizing, interpersonal, ... a maker of _possible_ with us. The Director of Regulatory Affairs reports directly to the Senior Director of... Affairs reports directly to the Senior Director of Regulatory Affairs. This position is responsible for supporting MMS… more
- BeOne Medicines (San Mateo, CA)
- …ethics committees + Lead the authoring and review of safety sections of regulatory submissions , eg, IND/CTA (General Investigational Plans, China Risk Control ... evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory -required periodic reporting._ _Physicians in this… more