Regulatory Submissions Manager Jobs in Dublin, CA | Glassdoor
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Regulatory Submissions Manager Jobs in Dublin, CA

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  • 3.2
    Dynavax Technologies – Berkeley, CA
    Est. Salary $201k-$266k
    10 days ago 10d
    Experience and knowledge in the preparation and submission of major regulatorysubmissions, supportive amendments, and supplements.… documents (content) and the final sign-off of regulatorysubmissions. Provide input to target labeling content (MDS, SmPC, US package…
  • Avispa – Pleasanton, CA
    Est. Salary $48k-$74k
    12 days ago 12d
    Administrative assistance with EPA and/or State label registration submissions, as needed. Administrative assistance with processing and… technical skills through previous professional experience Regulatory, environmental, toxicology or chemistry experience in a highly…
  • 3.6
    Agilent Technologies – Santa Clara, CA
    17 days ago 17d
    relevant regulatory experience with 2+ years in a leadership capacity, management preferred. - Experience with US submissions - Proven… Information about Agilent is available at www.agilent.com. Manages the submission, approval and maintenance of Agilent products into the…
  • Shockwave Medical – Fremont, CA
    EASY APPLY
    Est. Salary $78k-$119k
    17 days ago 17d
    development, case report form (CRF) development, IRB/Ethics submissions. Additionally, this position will develop site training… reports and clinical sections of Pre- or Post-Market Approval submissions Coordinate the design, format and content of CRFs, study…
  • 4.2
    ZELTIQ Aesthetics – Pleasanton, CA
    Est. Salary $116k-$175k
    10 days ago 10d
    accordance with corporate objectives • Generates and managesregulatorysubmission documents for new products or changes to existing… • Writes, submits, reviews, and coordinates global regulatorysubmissions (e.g. new product notifications, CE Mark Technical Files…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $74k-$109k
    11 days ago 11d
    be responsible for the timely production and submission of regulatory documentation, including INDs and IND amendments and license… interactions with regulatory authorities on identified projects, and for intercompany communications of regulatory issues and associated…
  • 4.2
    Avispa Technology – Pleasanton, CA
    Est. Salary $58k-$87k
    25 days ago 25d
    Administrative assistance with EPA and/or State label registration submissions, as needed. Administrative assistance with processing… technical skills through previous professional experience Regulatory, environmental, toxicology or chemistry experience in a highly…
  • 2.9
    System One – Pleasanton, CA
    24 days ago 24d
    Administrative assistance with EPA and/or State label registration submissions, as needed. Administrative assistance with processing and… technical skills through previous professional experience. Regulatory, environmental, toxicology or chemistry experience in a highly…
  • 3.0
    Bio-Rad Laboratories – Pleasanton, CA
    Est. Salary $80k-$122k
    25 days ago 25d
    will lead all regulatory strategies and manage the regulatory process to ensure approval from various regulatory agencies. This… Regulatory Affairs Manager Tracking Code BC16-R-046 Job Description Bio-Rad is a global leader…
  • 3.9
    Stryker – Fremont, CA
    Est. Salary $121k-$167k
    NEW
    general supervision of the Regulatory Affairs Department Manager or Director Prepares complex submissions to gain approvals for… ) preferred. Demonstrated success in management of regulatorysubmissions activities. Thorough understanding of global regulations…
  • 3.9
    Axelon, Inc. – Pleasanton, CA
    Est. Salary $89k-$118k
    25 days ago 25d
    Administrative assistance with EPA and/or State label registration submissions, as needed. Administrative assistance with processing… technical skills through previous professional experience Regulatory, environmental, toxicology or chemistry experience in a highly…
  • 2.9
    Bank of the West – San Ramon, CA
    Est. Salary $173k-$215k
    NEW
    for the submission of information and ensure that all information requested is submitted accurately and on time. Manages and leads… determining regulatory reporting requirements. Essential Job Functions Identifies, integrates and manages required internal…
  • 3.0
    Verseon – Fremont, CA
    Est. Salary $62k-$97k
    17 days ago 17d
    management efforts, preparing document packages for regulatorysubmissions in electronic formats, and supporting the Quality System… Location: Fremont, CA Regulatory Affairs Manager We are seeking a Regulatory Affairs Manager who is ready to help develop and…
  • 2.9
    Cerus Corporation – Concord, CA
    Est. Salary $73k-$113k
    NEW
    Job Brief (Primary Responsibilities) Manage assigned regulatory projects and/or submissions ensuring that Company products comply… represents Regulatory Affairs on project teams. Maintains regulatory filings or records, including archive of submissions and FDA…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $115k-$155k
    NEW
    Duties and Responsibilities: Develop and manageregulatorysubmissions such as 510(k), Investigational Device Exemptions… to define contributions to submissions for regulatorysubmissions. Interface with global regulatory authorities, strategic partner…
  • 3.1
    Natera – San Carlos, CA
    Est. Salary $156k-$210k
    4 days ago 4d
    for submissions to regulatory agencies worldwide. Executes department and cross functional projects, identifies regulatory activities… realistic regulatory strategies for a range of complex regulatory affairs programs with emphasis on requirements and submissions associated…
  • 5.0
    Intersect ENT – Menlo Park, CA
    Est. Salary $68k-$105k
    5 days ago 5d
    for regulatory project timelines and management of IND/NDA and global regulatorysubmissions. Lead regulatory activities… and nonclinical sections of regulatorysubmissions. Coordinate and prepare regulatorysubmissions (IND, NDA, IDE, 510k, PMA)…
  • 4.5
    AirXpanders – Palo Alto, CA
    Est. Salary $76k-$113k
    19 days ago 19d
    organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings… for submission to regulatory agencies or to commercial partners, advise on the submission strategy. Timely compile materials for…
  • 3.8
    Singulex – Alameda, CA
    Est. Salary $125k-$208k
    NEW
    requiring regulatory agency approval, as pertains to US and international regulatory requirements. Managesubmission activities… global product registrations. Manages FDA submissions, including Pre-IDE meeting planning, follow ups, and inspections.…
  • 3.1
    Natera – San Carlos, CA
    Est. Salary $68k-$99k
    NEW
    SUMMARY The Regulatory Affairs Specialist will be responsible for the preparation of regulatorysubmissions required to market… Develops strategies for submissions to FDA and other regulatory agencies. Provides risk assessments and regulatory options. Prepares…
  • 4.4
    Ascent Services Group – Palo Alto, CA
    10 days ago 10d
    to regulations and applicable guidelines for all regulatorysubmissionsManage timelines to ensure approvals are timely and development… various regulatory scenarios Participate in the electronic review and quality verification of regulatorysubmissions Manage…
  • 5.0
    Strategic Employment Partners – Redwood City, CA
    Est. Salary $58k-$92k
    4 days ago 4d
    apply. Responsibilities: Write, prepare, and manageregulatorysubmissions and filings required for FDA and other International… to ensure submission approval Requirements: Experience with communicating with EU/US and foreign regulatory bodies…
  • 3.9
    Stryker Corporation – Fremont, CA
    Est. Salary $121k-$168k
    6 days ago 6d
    general supervision of the Regulatory Affairs Department Manager or Director Prepares complex submissions to gain approvals for… preferred. Demonstrated success in management of regulatorysubmissions activities. Thorough understanding of global regulations…
  • 3.5
    Relypsa Inc. – Redwood City, CA
    Est. Salary $91k-$132k
    4 days ago 4d
    Relypsa SOPs, where appropriate Independently manage routine regulatorysubmissions (e.g., Annual Reports, DSURs, Investigator Updates… , safety, efficacy, and labeling) to be included in regulatorysubmissions (e.g., IND, CTA, NDA, MAA) for accuracy and completeness…
  • 2.8
    Agilent Technologies UK Ltd – Santa Clara, CA
    12 days ago 12d
    relevant regulatory experience with 2+ years in a leadership capacity, management preferred. Experience with US submissions Proven… about Agilent is available at ***************. Manages the submission, approval and maintenance of Agilent products into the…
  • 3.5
    Cardinal Health – Milpitas, CA
    Est. Salary $53k-$81k
    4 days ago 4d
    years of experience in regulatorysubmissions required. Experience in direct communication with regulatory agencies. Prior experience… and international regulatory filings such as 510(k), IDE, PMA, Annual Reports, and Design Dossier submissions, including subsequent…
  • 3.9
    Planet Pharma – Palo Alto, CA
    Est. Salary $90k-$131k
    10 days ago 10d
    to regulations and applicable guidelines for all regulatorysubmissionsManage timelines to ensure approvals are timely and development… various regulatory scenarios Participate in the electronic review and quality verification of regulatorysubmissions Manage…
  • 2.6
    Astex Pharmaceuticals – Pleasanton, CA
    Est. Salary $160k-$212k
    16 days ago 16d
    CMC regulatory review for regulatorysubmissions and regulatory processes. This individual will represent CMC Regulatory Affairs… participate on RegulatorySubmission Teams, create timelines for complete and accurate IND/CTA and NDA/MAA submissions, ensure that…
  • 3.5
    SRI International – Menlo Park, CA
    Est. Salary $57k-$79k
    20 days ago 20d
    CMC technical reports, toxicology report compilation and submission, project coordination between functional groups and ensuring… Analytical Chemistry, Formulation, Quality Assurance and Regulatory Affairs. The successful PM candidate will write CMC technical…
  • 3.5
    Cardinal Health – Milpitas, CA
    NEW
    years of experience in regulatorysubmissions required. Experience in direct communication with regulatory agencies. Prior experience… and international regulatory filings such as 510(k), IDE, PMA, Annual Reports, and Design Dossier submissions, including subsequent…
  • 3.5
    Abbott – Santa Clara, CA
    Est. Salary $106k-$144k
    12 days ago 12d
    review and submit regulatorysubmission to authorities · Monitor impact of changing regulations on submission strategies and update… and regulatory process · Lead functional groups in the development of relevant data to complete a regulatorysubmission Communication…
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