Associate Director, Regulatory Affairs Submissions Jobs in Palo Alto, CA | Glassdoor
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Associate Director, Regulatory Affairs Submissions Jobs in Palo Alto, CA

43 Jobs

  • 5.0
    Dermira Inc. – Menlo Park, CA
    $109k-$214k(Glassdoor est.)
    NEW
    projects. Collaborate with RegulatoryAffairs and contributing functional areas to create submission project plans as well as identify… preparation of regulatorysubmissions (project management, resource scheduling, formatting, publishing, QC, archive and submission) Lead…
  • 3.2
    Gilead Sciences – Foster City, CA
    $154k-$204k(Glassdoor est.)
    13 days ago 13d
    departments outside of RegulatoryAffairs. Responsible for submitting or ensuring submission of all regulatory documents required… contacts with local Regulatory Authorities. Participates in industry trade groups and regulatoryaffairs professional societies…
  • 3.5
    Singulex – Alameda, CA
    $126k-$209k(Glassdoor est.)
    5 days ago 5d
    requiring regulatory agency approval, as pertains to US and international regulatory requirements. Manage submission activities… degree preferred or a focused degree in RegulatoryAffairs. 10+ years related regulatory experience In-vitro diagnostic (reagents…
  • 3.1
    Excelitas Technologies – Fremont, CA
    $122k-$175k(Glassdoor est.)
    12 days ago 12d
    site and reports directly to Corporate Senior Director of Global RegulatoryAffairs and Compliance. RESPONSIBILITIES: Provide… ISO13485, FDA QSR , FDA 510K Submission and Registration with FDA and other relevant Medical Device Regulatory Bodies. This position…
  • 3.1
    Natera – San Carlos, CA
    $158k-$213k(Glassdoor est.)
    8 days ago 8d
    realistic regulatory strategies for a range of complex regulatoryaffairs programs with emphasis on requirements and submissions associated… SUMMARY The Director, RegulatoryAffairs leads, plans, coordinates, conducts and reports on regulatory registration programs…
  • 5.0
    MyoKardia, Inc. – South San Francisco, CA
    $57k-$131k(Glassdoor est.)
    NEW
    to the Head of RegulatoryAffairs. ESSENTIAL DUTIES & RESPONSIBILITIES Develop and implement regulatory strategies to facilitate… experience with pharmaceutical regulatorysubmissions and product approvals, managing major regulatory filing(s) such as IND/CTA or…
  • 4.0
    Versartis – Menlo Park, CA
    $176k-$286k(Glassdoor est.)
    13 days ago 13d
    Works with Manufacturing, Quality, Validation, RegulatoryAffairs, Medical Affairs and Clinical Operations to provide global Medical… closely with the Manufacturing, Validation, Quality, and RegulatoryAffairs functions internally and at the CMO sites to ensure all…
  • 3.2
    Gilead Sciences – Foster City, CA
    $164k-$258k(Glassdoor est.)
    NEW
    and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough… Safety Committee Provide input into clinical data for regulatorysubmissions as requested by Project Team Commercial support…
  • 1.8
    Pharmacyclics – Sunnyvale, CA
    $161k-$217k(Glassdoor est.)
    21 days ago 21d
    The AssociateDirector/Director of RegulatoryAffairs, under the accountability of the Senior Director, RegulatoryAffairs, helps… attend and provide regulatory support to other departments, project teams, and committees. Organize/manage submissions to health authorities…
  • 4.0
    Stryker – Fremont, CA
    $110k-$152k(Glassdoor est.)
    6 days ago 6d
    general supervision of the RegulatoryAffairs Department Manager or Director Prepares complex submissions to gain approvals for… Principal RegulatoryAffairs Specialist Group MedSurg and Neurotech Division Neurovascular Business Function Regulatory Affairs…
  • 4.7
    Shockwave Medical – Fremont, CA
    EASY APPLY
    19 days ago 19d
    conformance with applicable regulatory requirements to meet business objectives. The Director of Clinical Affairs will establish processes… plaque. The Director of Clinical Affairs will play a key leadership role for the Company’s Clinical Affairs including study…
  • 5.0
    Dermira, Inc. – Menlo Park, CA
    $109k-$214k(Glassdoor est.)
    NEW
    ensuring they meet the technical and regulatory requirements. Support regulatorysubmissions by writing, reviewing, and approving… the Pharmaceutical Sciences team as well as Quality, RegulatoryAffairs, Commercial Operations, Finance, and IT. ESSENTIAL…
  • 3.3
    Relypsa Inc. – Redwood City, CA
    $132k-$177k(Glassdoor est.)
    27 days ago 27d
    Summary: The AssociateDirector, RegulatoryAffairs will be responsible for performing or managing key regulatory activities for… Participate on RegulatoryAffairs sub teams for activities related to the development of labeling for regulatorysubmissions.…
  • 2.9
    Ultragenyx Pharmaceuticals – Brisbane, CA
    $165k-$220k(Glassdoor est.)
    NEW
    Create and maintain regulatory timelines and track deliverables to timelines to ensure that regulatorysubmission timelines are met… appropriate regulatory strategies to mitigate risks Develop and/or review regulatory documents to ensure that all submissions are of…
  • 5.0
    Dermira Inc. – Menlo Park, CA
    $109k-$214k(Glassdoor est.)
    NEW
    ensuring they meet the technical and regulatory requirements. Support regulatorysubmissions by writing, reviewing, and approving… the Pharmaceutical Sciences team as well as Quality, RegulatoryAffairs, Commercial Operations, Finance, and IT. ESSENTIAL…
  • 1.8
    Pharmacyclics – Sunnyvale, CA
    $161k-$217k(Glassdoor est.)
    NEW
    The AssociateDirector/Director of RegulatoryAffairs, under the accountability of the Senior Director, RegulatoryAffairs, helps… Regulatory Affairs - Pharmacyclics - 2038 2038 Search Jobs Director, RegulatoryAffairsRegulatoryAffairs Sunnyvale…
  • 4.4
    Ascent Services Group – Redwood City, CA
    12 days ago 12d
    new drug) applications and filings. Supports RegulatoryAffairs on clinical development aspects of filings; plays a central role… /her manager Works with Regulatory and other partners/stakeholders in the completion and submission of IND (investigational new…
  • 3.4
    Becton Dickinson and Company – San Jose, CA
    $119k-$164k(Glassdoor est.)
    5 days ago 5d
    assisting Sr. Director of RegulatoryAffairs to ensure department processes and procedures related to regulatory responsibilities… Description The Staff RegulatoryAffairs (RA) Specialist is responsible for establishing and maintaining regulatory operating systems…
  • 3.2
    Prothena – South San Francisco, CA
    $128k-$172k(Glassdoor est.)
    5 days ago 5d
    planned objectives, the AssociateDirector of RegulatoryAffairs will be responsible for developing regulatory strategies, planning… work with the Director of RegulatoryAffairs and global regulatory team towards the development of global regulatory strategies…
  • 3.5
    Abbott – Alameda, CA
    $168k-$226k(Glassdoor est.)
    26 days ago 26d
    Summary The function of Director, RegulatoryAffairs is to combine knowledge of scientific, regulatory and business issues to enable… and procedures for regulatoryaffairs and compliance to establish a compliant culture. Anticipate regulatory and related obstacles…
  • 5.0
    Dermira, Inc. – Menlo Park, CA
    $109k-$214k(Glassdoor est.)
    6 days ago 6d
    projects. Collaborate with RegulatoryAffairs and contributing functional areas to create submission project plans as well as identify… Senior Manager/AssociateDirector, Regulatory Operations JOB SUMMARY: Responsible for the daily operational activities…
  • 3.2
    Gilead Sciences – Foster City, CA
    $164k-$258k(Glassdoor est.)
    15 days ago 15d
    The Senior Director, Global Medical Affairs, HEM-ONC will report into the Senior Vice President of Medical Affairs. Below outlines… and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough…
  • 3.3
    Relypsa – Redwood City, CA
    7 days ago 7d
    colleagues in the field and office-based clinical, medical affairs, and drug safety team members, so that key clinical, safety… in investigator sponsored trials (IST), and supporting IST submissions through appropriate internal review and approval processes…
  • 3.2
    Intarcia Therapeutics, Inc. – Hayward, CA
    $116k-$276k(Glassdoor est.)
    21 days ago 21d
    At least 4 years of regulatoryaffairs with experience associated with leading NDA and global submissions. Must have comprehensive… key member of our diverse regulatoryaffairs team, the Director/Senior Director, RegulatoryAffairs will be responsible for developing…
  • 4.0
    Jazz Pharmaceuticals – Palo Alto, CA
    12 days ago 12d
    project team members, regulatoryaffairs and senior management Serve as medical representative with regulatory agencies Identify… Interpret clinical trial data and prepare reports, regulatorysubmissions and publications based on the results Monitor clinical…
  • 3.6
    AstraZeneca – Redwood City, CA
    19 days ago 19d
    of smaller global function such as CMC, regulatoryaffairsdirectors, associatedirectors and managers, managing health authority… Works collaboratively with the global/regional/local regulatoryaffairs staff at Acerta and AstraZeneca, to influence developing…
  • 4.3
    Guardant Health – Redwood City, CA
    EASY APPLY
    $196k-$309k(Glassdoor est.)
    16 days ago 16d
    externally. Partners with internal stakeholders from regulatoryaffairs, medical affairs, biostatistics, technology development, business… technology validation, or research activities supporting regulatorysubmissions and/or reimbursement. Projects may include company sponsored…
  • 3.0
    Absolute Opportunities – Santa Clara, CA
    $89k-$142k(Glassdoor est.)
    12 days ago 12d
    Senior RegulatoryAffairs Specialist - RT Santa Clara, California 95052 Senior RegulatoryAffairs Specialist - RT IDEAL… specific regulatorysubmission files Collect and coordinate information and prepare regulatory documentation for submission to regulatory…
  • Protagonist Therapeutics – Newark, CA
    NEW
    QA regulatory inspections and providing inspection responses. Specific Responsibilities: The AssociateDirector of cGCP… Pre-Clinical, Clinical Operations, Quality, Finance and RegulatoryAffairs; Establish and maintain documentation specific (Quality…
  • AstraZeneca Pharmaceuticals LP – Redwood City, CA
    6 days ago 6d
    of smaller global function such as CMC, regulatoryaffairsdirectors, associatedirectors and managers, managing health authority… Works collaboratively with the global/regional/local regulatoryaffairs staff at Acerta and AstraZeneca, to influence developing…
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