- Gilead Sciences, Inc. (Foster City, CA)
- …experience in digital or innovation roles preferred. + Strong understanding of CMC regulatory submissions and the structure/content of Module 3. + [Preferred]: ... enterprise platforms. + Prioritize use cases across submission acceleration, regulatory intelligence, authoring automation, and knowledge reuse. + Translate… more
- Gilead Sciences, Inc. (Foster City, CA)
- …portfolio. This position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions , and "right to operate" by maintaining the ... respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director, CMC Regulatory Affairs for Biologics is responsible for defining ...global clinical or commercial submissions . In addition, you will be accountable for leading… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in scope, as teams are working earlier on TPPs and product strategies. . ** Regulatory Operations & Submissions ** Oversee the drafting, review, and approval of ... Description** . **Strategic Leadership & Vision** Define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and… more
- BeOne Medicines (Emeryville, CA)
- …Veeva RIM and help to enable efficiencies therein. Provide leadership to Regulatory Submissions Operations Management teams (eg Regional Submission Operations, ... and regulatory agencies on evolving guidance and technologies impacting submissions . + Manage external vendors, ensuring clarity on expectations, timelines, and… more
- Medtronic (Northridge, CA)
- …clear, concise, and well-structured test plans and reports to support regulatory submissions . This role involves coordinating required chemical characterization ... testing, and authoring clear, concise, and well-structured reports to support regulatory submissions . This position involves close collaboration with… more
- Kelly Services (Sunnyvale, CA)
- …manage multiple responsibilities effectively. + Support software tools for organizing regulatory files, registration tracking, documentation for submissions and ... Kelly(R) Science & Clinical is seeking a Regulatory Affairs Process Specialist for a 6-month contract opportunity with a leading molecular diagnostics company based… more
- Actalent (Vista, CA)
- …Reports or Medical Device Reports to Competent Authority or FDA. + Review regulatory submissions and assign signature for approval. + Manage quality control ... The QA Specialist is primarily responsible for overseeing the quality and regulatory aspects of the company. This includes the development and maintenance of… more
- Lilly (San Diego, CA)
- …FDA interactions, and global development planning + Contribute medical expertise to regulatory submissions and agency communications + Support risk management ... from early clinical studies and enable early decision-making + Contribute to regulatory interactions, including pre-IND, IND submissions , interactions to ex-US… more
- Amgen (Thousand Oaks, CA)
- …highest quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development programs. This role is ... of clinical data standards (CDISC, SDTM, ADaM). + Experience leading regulatory submissions , including NDA/BLA/MAA filings and advisory committee interactions… more
- Abbott (Alameda, CA)
- …product related queries. *Generate literature summaries and technical write-ups for regulatory submissions . *Support writing papers and presentations for ... Medical Affairs). *Creates/updates technical documents for medium risk product international regulatory submissions (eg, IVDR Class C/D and/or novel).… more