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Regulatory Submissions Manager Jobs

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  • 3.5
    Wells Fargo – Charlotte, NC
    NEW
    preparing SEC and regulatory reports and ensuring the adequacy of internal controls. The Division also manages and supports the… production across regulatory and SEC reporting and across all segments of the Company. The Automated Regulatory Reporting team is…
  • 3.5
    Wells Fargo – Minneapolis, MN
    NEW
    preparing SEC and regulatory reports and ensuring the adequacy of internal controls. The Division also manages and supports the… production across regulatory and SEC reporting and across all segments of the Company. The Automated Regulatory Reporting team is…
  • 2.9
    Apex Life Sciences – San Rafael, CA
    Est. Salary $61k-$128k
    NEW
    Duties: ManageRegulatory Sub-team operations, including facilitation of Subteam and Strategy meetings (schedule, prepare… maintain reporting dashboards for teams and management. Track submission preparation progress, including but not limited to post-marketing…
  • 2.9
    Genesis Financial Solutions, Inc. – Beaverton, OR
    Est. Salary $66k-$106k
    9 days ago 9d
    We strive to contact qualified applicants within a week of submission. Unfortunately, we are currently unable to provide sponsorship… Sophisticated analytics, high-quality execution, strict adherence to regulatory and compliance requirements and an unmatched expertise in…
  • 3.1
    TechUSA – York, PA
    11 days ago 11d
    and prepare submissions for regulatory authorities for successful approvals. Collaboration with in-house regulatory and quality… broad understanding of regulatory requirements Preparation, compilation, and review of regulatorysubmissions for devices Prepare…
  • 3.6
    Lake Trust Credit Union – United States
    NEW
    timely submission and accuracy of team member 401 K payroll contributions an employer match deposits with plan. Manage and administer… governing leaves. Manage record retention and ensure documents are retained in compliance with required regulatory record keeping…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    Est. Salary $65k-$116k
    NEW
    experienced medical writer with experience in preparing key summary submission documents (eg, Clinical Summary of Safety, Clinical Summary… Medical Affairs, Regulatory, and Program Management in planning and preparation of high quality clinical and regulatory documents, including…
  • 3.3
    Huntington National Bank – Columbus, OH
    NEW
    assurance testing over regulatory financial filings, including bank call reporting and capital plan submissions. The position will… and conformance with regulatory instructions of the monthly, quarterly, and annual financial regulatory filings submitted to the…
  • 3.1
    Chart Industries – Canton, GA
    Est. Salary $58k-$83k
    10 days ago 10d
    the required product approvals including document submissions to regulatory authorities and notified bodies. Proactively maintain… including submission of renewal paperwork. Work with Engineering on new product releases and changes to develop Regulatory Plans…
  • 3.3
    ALDI – Batavia, IL
    Est. Salary $73k-$121k
    5 days ago 5d
    preparation and submission of documentation to regulatory agencies and other external bodies required to respond to regulatory inquiries… Corporate Buying Quality Assurance Manager - Regulatory For consideration, please email your resume and/or your Employment Application…
  • 2.6
    Revlon – Edison, NJ
    NEW
    or analyses, evaluations, preparations and submissions of documentation for regulatory registration and/or governmental approval… market, as requested. Meets on a weekly basis with the Manager, Regulatory Affairs to provide progress report and advise of any…
  • 4.3
    bluebird bio – Cambridge, MA
    9 days ago 9d
    pharmaceutical industry. Experience with BLAs, MAAs and other regulatorysubmissions is a plus Proven expert in all SAS language, procedures… data in Tables, Listings, and Figures, and for electronic submissions of SDTM, ADaM datasets in CDlSC format, with minimal instruction…
  • Joule – Whippany, NJ
    Est. Salary $74k-$110k
    4 days ago 4d
    graphics. Prepare, review and manage change control for product labeling. Prepare FDA submissions, as required Review… Title: ManagerRegulatory Affairs, Consumer Health Location: Whippany, NJ Duration: December 2017 Requirements: Bachelors…
  • 2.5
    Medpace – United States
    Est. Salary $87k-$161k
    10 days ago 10d
    Oversee global publishing and submission process for domestic and international regulatory bodies; Manage the process from inception… and create nimble high performing teams. Experienced manager of Regulatory Operations staff and processes with a focus on delivery…
  • 4.0
    Tesaro – Waltham, MA
    Est. Salary $80k-$120k
    6 days ago 6d
    datasets that are conducive to analysis and a possible regulatorysubmission •Develop and support creation of data management documentation… in accordance with GCP, GCMP, internal SOPs, and meet all regulatory requirements •Leads and/or contributes to department initiatives…
  • 3.7
    Pfizer – Peapack, NJ
    Est. Salary $85k-$130k
    1 days ago 1d
    responsible for the development of initial CMC regulatory strategies, submissions and compliance activities for pharmatherapeutic… the initial preparation of CMC information for submission to global regulatory agencies, generates and drives CMC strategies,…
  • 3.4
    Takeda Pharmaceuticals – Cambridge, MA
    Est. Salary $121k-$174k
    10 days ago 10d
    POSITION ACCOUNTABILITIES: Plans, executes and managesregulatorysubmissions for assigned compounds with appropriate supervision… CMC content (data and documentation) requirements for regulatorysubmissions and reviews this content for conformance with established…
  • 2.9
    CareSource (Ohio) – Hilliard, OH
    Est. Salary $55k-$88k
    24 days ago 24d
    prior to submission to regulatory agencies Coordinate and compose time sensitive responses to incoming regulatory and legislative… Requisition Number 17-0813 Post Date 6/1/2017 Title Regulatory Contract Manager City Hilliard State OH Description Role…
  • 3.6
    NantWorks – Rockville, MD
    Est. Salary $64k-$91k
    NEW
    Companion Diagnostic and/or other Medical Device submissions, preferred REQUIRED COMPETENCIES KNOWLEDGE, SKILLS, ABILITIES… directly and consistently with R&D, Operations, Quality, and Regulatory personnel within the company, and may also support the efforts…
  • 3.6
    FibroGen – San Francisco, CA
    15 days ago 15d
    Experience with Clinical Study Reports and NDA submission. Understanding of regulatory guidelines that affect statistical deliverable… Manager/Sr. Manager, Statistical Programming Scope of Responsibilities The Manager/Sr. Manager (title will be based on…
  • 3.3
    Verathon – Bothell, WA
    Est. Salary $87k-$130k
    19 days ago 19d
    Senior Manager, Regulatory Affairs - Verathon® Verathon® is looking for a Senior Regulatory Affairs Manager to become a… approval for product submissions to FDA and other worldwide regulators for Verathon’s products. Manage the planning, execution…
  • 3.8
    Goldman Sachs – Jersey City, NJ
    Est. Salary $139k-$247k
    17 days ago 17d
    interests in the changing global regulatory landscape • Awareness and ability to identify and manage risks and develop control environment… ensuring compliance with applicable global regulatory requirements, supporting the regulatory change environment and maintaining relationships…
  • 3.4
    Takeda Pharmaceuticals – Cambridge, MA
    Est. Salary $121k-$174k
    8 days ago 8d
    facilitation and preparation of Emerging Markets regulatory documents and various submissions, as well as any compliance matters; Applies… POSITION ACCOUNTABILITIES: Executes the regulatorysubmissions to support product development and approval efforts…
  • Shockwave Medical – Fremont, CA
    EASY APPLY
    Est. Salary $78k-$119k
    16 days ago 16d
    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…
  • 2.6
    Genex Services – Los Angeles, CA
    Est. Salary $57k-$80k
    9 days ago 9d
    Compiling a case inventory on a monthly basis for submission to the branch manager to allow for proper billing and to calculate hours… necessary paperwork for the insurance company, state, or other regulatory bodies. Maintaining the necessary credentials and demonstrates…
  • 3.1
    Bausch & Lomb – Bridgewater, NJ
    Est. Salary $94k-$138k
    6 days ago 6d
    with regulatory requirements Coordinate with SubmissionsManager to ensure timely and accurate submissions to Regulatory Authorities… we hope it will become. The Regulatory Affairs Manager is responsible to implement regulatory accountabilities for the assigned…
  • 2.7
    Syneron Candela – Wayland, MA
    Est. Salary $85k-$126k
    NEW
    responsibilities of this position are to manage the regulatorysubmission / approval processes for all Syneron Candela products in all… international regulatory agencies. Develops regulatorysubmission strategies for FDA, Notified Bodies and other regulatory agency product…
  • 1.9
    Curo Health Services – Mooresville, NC
    Est. Salary $54k-$76k
    6 days ago 6d
    compiles reports related to submissions and other data as deemed necessary Manage and maintain files Manages special projects, as… POSITION PURPOSE: The Regulatory Analyst is responsible for ensuring that required contracts, applications, and credentialing…
  • 3.6
    PRA Health Sciences – Chicago, IL
    Est. Salary $124k-$172k
    23 days ago 23d
    and regulatorysubmission filings Maintains fluency with regulatory agency submission publishing and validation standards to… worldwide e-submission filings. Drives the submission process; creates and supports the electronic management of regulatory submissions…
  • 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…
  • 3.3
    Dannon – Minster, OH
    NEW
    documentation control and system testing for regulatory team •Influence regulatory direction and drive strategy on cross-functional… analysis •Orchestrate nutrition analytical testing, sample submission and documentation management •Coordinate non-GMO Project…
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