- Cardinal Health (Sacramento, CA)
- **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations uses specialized technology and knowledge ... and compile paper and electronic documents related to the pharmaceutical industry regulatory submissions throughout each phase of drug development and though… more
- Abbott (Santa Clara, CA)
- …units that Leverage Services team supports, including the execution of strategic regulatory initiatives, regulatory submissions , agency relationship and ... leadership experience to support the medical device business units with their regulatory submissions . Collaborates closely with internal regulatory … more
- Kelly Services (Sunnyvale, CA)
- …assay, instrument, software projects and/or system projects. **Responsibilities** + Prepare regulatory submissions and interacts cross-functionally to ensure OTD ... the initial product launch (US, EU, WHO/PQ). + Authors and prepare regulatory submissions (US-FDA, IVDR, WHO/PQ) as required by project plan. + Prepares formal… more
- AbbVie (Irvine, CA)
- …enable first pass approvals. Develops and manages content strategy for regulatory submissions , including INDs/CTAs and amendments, new marketing applications ... + Prepares device regulatory product strategies. Prepares and manages regulatory submissions , including new applications and amendments, renewals annual… more
- Caldera Medical (Westlake Village, CA)
- …approvals from worldwide regulatory bodies. From developing and authoring regulatory submissions to providing critical input on cross-functional project ... and quality system procedures. * Reviews protocols and reports to support regulatory submissions . * Maintain proficiency in global quality and regulatory … more
- Abbott (Alameda, CA)
- …life Sciences, Biology (or equivalent vocational qualifications) + Experienced in regulatory submissions for Pharmaceuticals, medical devices, and/or in vitro ... regulations or with EU and other international medical device regulations and submissions . + Familiar with relevant regulatory requirements for medical devices,… more
- Abbott (Santa Clara, CA)
- …clinical documentation for submission filing. + Compile, prepare, review and submit regulatory submissions to authorities. + Monitor impact of changing ... life Sciences, Biology (or equivalent vocational qualifications) + Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC ... planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with… more
- GRAIL (Menlo Park, CA)
- …degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... information, please visit grail.com . The role assists with regulatory strategy and the development of submissions ...with regulatory strategy and the development of submissions in partnership with key internal and external stakeholders… more
- Cardinal Health (Sacramento, CA)
- **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations provides regulatory affairs and product ... to provide services in technical writing, scientific data verification, and basic regulatory submissions within the discipline of chemistry, manufacturing, and… more