Associate Director, Regulatory Affairs Submissions Jobs in Santa Clara, CA | Glassdoor
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Associate Director, Regulatory Affairs Submissions Jobs in Santa Clara, CA

33 Jobs

  • 3.2
    Gilead Sciences – Foster City, CA
    $164k-$258k(Glassdoor est.)
    6 days ago 6d
    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.)
    25 days ago 25d
    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…
  • 3.4
    BD – San Jose, CA
    $119k-$164k(Glassdoor est.)
    4 days ago 4d
    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…
  • 4.7
    Shockwave Medical – Fremont, CA
    EASY APPLY
    HOT
    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…
  • 1.8
    Pharmacyclics – Sunnyvale, CA
    $161k-$217k(Glassdoor est.)
    5 days ago 5d
    The AssociateDirector/Director of RegulatoryAffairs, under the accountability of the Senior Director, RegulatoryAffairs, helps… Regulatory Affairs - Pharmacyclics - 2038 2038 Search Jobs Director, RegulatoryAffairsRegulatoryAffairs Sunnyvale…
  • 3.2
    Intarcia Therapeutics, Inc. – Hayward, CA
    $90k-$130k(Glassdoor est.)
    NEW
    of the RegulatoryAffairs team, the Manager, RegulatoryAffairs is responsible for direct interactions with regulatory authorities… representing RegulatoryAffairs and foster positive and productive working relationships between project team members and regulatory agency…
  • 3.1
    Natera – San Carlos, CA
    $158k-$213k(Glassdoor est.)
    26 days ago 26d
    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…
  • 3.3
    Relypsa Inc. – Redwood City, CA
    $132k-$177k(Glassdoor est.)
    NEW
    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.…
  • 3.2
    Intarcia Therapeutics, Inc. – Hayward, CA
    $116k-$276k(Glassdoor est.)
    HOT
    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…
  • 3.2
    Gilead Sciences – Foster City, CA
    $154k-$204k(Glassdoor est.)
    16 days ago 16d
    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…
  • 1.8
    Pharmacyclics – Sunnyvale, CA
    $236k-$373k(Glassdoor est.)
    NEW
    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…
  • 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…
  • 3.0
    Absolute Opportunities – Santa Clara, CA
    $89k-$142k(Glassdoor est.)
    16 days ago 16d
    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…
  • 4.0
    Stryker – Fremont, CA
    $110k-$152k(Glassdoor est.)
    10 days ago 10d
    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…
  • 3.2
    Gilead Sciences – Foster City, CA
    $164k-$258k(Glassdoor est.)
    19 days ago 19d
    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…
  • 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 DUTIES…
  • 3.2
    Intarcia Therapeutics, Inc. – Hayward, CA
    $168k-$227k(Glassdoor est.)
    10 days ago 10d
    required. At least 3 years of regulatoryaffairs with experience associated with global submissions. Must have comprehensive understanding… Opportunity As a key member of our RegulatoryAffairs department, the Director, RegulatoryAffairs (Early Development) will be responsible…
  • 3.1
    Excelitas Technologies – Fremont, CA
    $122k-$175k(Glassdoor est.)
    16 days ago 16d
    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…
  • 4.3
    Guardant Health – Redwood City, CA
    EASY APPLY
    $196k-$309k(Glassdoor est.)
    19 days ago 19d
    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…
  • Protagonist Therapeutics – Newark, CA
    4 days ago 4d
    Pre-Clinical, Clinical Operations, Quality, Finance and RegulatoryAffairs; Establish and maintain documentation specific (Quality… Assist with the preparation and review of clinical regulatorysubmissions for USA and worldwide health agencies. Requirements…
  • 5.0
    Dermira, Inc. – Menlo Park, CA
    $109k-$214k(Glassdoor est.)
    5 days ago 5d
    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…
  • 3.6
    AstraZeneca – Redwood City, CA
    23 days ago 23d
    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…
  • AstraZeneca Pharmaceuticals LP – Redwood City, CA
    NEW
    with Medical Affairs in support of ISTs and publications. Interacting closely with the Regulatory group and regulatory agencies,… : pre-clinical, manufacturing, quality assurance, regulatory, medical affairs, marketing, legal, biostatistics and data management…
  • 4.0
    Versartis – Menlo Park, CA
    $176k-$286k(Glassdoor est.)
    HOT
    Works with Manufacturing, Quality, Validation, RegulatoryAffairs, Medical Affairs and Clinical Operations to provide global Medical… relevant documentation for GMP Production, Operations and Regulatorysubmissions for global registration of Versartis’ product to ensure…
  • 5.0
    Dermira, Inc. – Menlo Park, CA
    $127k-$209k(Glassdoor est.)
    NEW
    the Pharmaceutical Sciences team as well as Quality, RegulatoryAffairs, Commercial Operations, Finance, and IT. Essential… Participate in regulatory strategy development, regulatory filings, and meetings with regulatory agencies. Support regulatory submissions…
  • 4.0
    Jazz Pharmaceuticals – Palo Alto, CA
    16 days ago 16d
    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…
  • 4.0
    Stryker Corporation – Fremont, CA
    $110k-$152k(Glassdoor est.)
    30+ days ago 30d+
    general supervision of the RegulatoryAffairs Department Manager or Director Prepares complex submissions to gain approvals for… with in-country RegulatoryAffairs personnel to facilitate global clearances/approvals. Develops global regulatory strategies for…
  • 3.6
    AstraZeneca – Redwood City, CA
    30+ days ago 30d+
    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…
  • 1.6
    Revance Therapeutics, Inc. – Newark, CA
    $176k-$278k(Glassdoor est.)
    8 days ago 8d
    organizations, industry associations, standards organizations, and regulatory group meetings regarding clinical and regulatory expertise. The… collaboration with the Biometrics, Clinical Operations, and Medical Affairs groups. Recruit, guide, and motivate clinical investigators…
  • AstraZeneca Pharmaceuticals LP – Redwood City, CA
    10 days ago 10d
    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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