- Sumitomo Pharma (Sacramento, CA)
- …and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and ... Manager of Regulatory Operations is responsible for managing all Regulatory Affairs activities involving compilation, publishing , distribution, and archiving… more
- BeOne Medicines (Emeryville, CA)
- …bonus. . eCTD Validator software experience (eg Lorenz, EURS is Yours) . Regulatory Submission Publishing experience required . Document management systems (eg ... **General** **Description:** This position resides in the Global Regulatory Operations Strategy & Innovation and will interact at all levels, including BeOne's… more
- Vera Therapeutics (Brisbane, CA)
- …for briefing documents and agency meetings. * Coordinate submission scheduling with regulatory publishing and ensure delivery of high-quality documents. * May ... our lead late-stage development Program, Atacicept, in alignment with Vera's Regulatory strategy and our commitment to health authorities globally. Responsibilities:… more
- AbbVie (Irvine, CA)
- …role must effectively interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Development Operations. Responsibilities + Leads the ... sets for individual studies and integrated data. + Creates documentation for regulatory filings including reviewers guides and data definition documents. + Leads the… more
- AbbVie (South San Francisco, CA)
- …Programming must effectively interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations. Responsibilities + Leads ... sets for individual studies and integrated data. + Creates documentation for regulatory filings including reviewers guides and data definition documents. + Leads the… more
- Insight Global (San Diego, CA)
- …familiarity of web application technology, electronic document management systems, electronic publishing systems for regulatory filings, and exposure in database ... of Veeva and its support functions including: clinical, quality, safety& regulatory Experience with ERP Experience with Microsoft applications technologies such as… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Become a **maker of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist, you will play a crucial role in supporting Medication Management ... associated software, and accessories on a global scale. **Responsibilities** + Support regulatory efforts to comply with new and existing US and international… more
- Terumo Neuro (Aliso Viejo, CA)
- **12814BR** **Title:** Sr. Specialist, Regulatory Affairs **Job Description:** Responsible for preparing strategy for worldwide product approval submission ... focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral devices. Job duties: +… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Become a **maker of possible** with us. **Primary** **Responsibilities:** + Support regulatory effort to comply with new and existing regulations (eg, FDA Medical ... Device Regulations, EU-MDR) + Problem solve and escalate regulatory and compliance issues to senior management as necessary + Drive continuous improvement in… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** + This position supports Regulatory Affairs personnel in the coordination, preparation, and submission of all INDs/NDAs/MAAs and life cycle ... and actively resolve technical issues. + Responsible for both report level publishing and submission level compilation for global major applications and lifecycle… more
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