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Senior regulatory submissions manager Jobs

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  • 3.7
    bluebird bio – Cambridge, MA
    3 days ago 3d
    cGxP approved documentation. Manage the data integrity (QC) program to ensure data in regulatory filings has been verified against… include Quality review of all regulatory filings, coordination of Quality responses to regulatory authorities, and key member of…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $89k-$147k
    2 days ago 2d
    workflow and manage regulatory submission teams; create and track regulatory CMC submission timelines. • Support CMC regulatory activities… and investigational submissions as well as subsequent submissions (e.g., FDA Information Requests, Regulatory commitments, Day 120…
  • 3.3
    Shire Pharmaceuticals LLC – Westlake Village, Los Angeles, CA
    21 days ago 21d
    The Submissions Manager is responsible for the planning, publishing (paper, NeES, eCTD), review and dispatch of regulatory submissions… Plan and publish regulatory submissions, ensuring timely submission of high quality, compliant and valid submissions to global health…
  • 3.3
    PAREXEL – United States
    8 days ago 8d
    ! The Senior Regulatory Associate is a departmental leader in the production of submissions and delivery of regulatory services… current global regulatory submission standards, 5-7 years previous experience required • Overall understanding of Regulatory CMC, Labeling…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    Est. Salary $58k-$118k
    10 days ago 10d
    Therapeutics is currently seeking a Contract NDA Submission Project Manager to fill a role on site for up to 1 year. Responsibilities… Qualifications Experience in the submission and approvals of NDAs and MAAs in the role of project manager. Thorough understanding of…
  • 3.7
    Amgen – Thousand Oaks, CA
    Est. Salary $73k-$131k
    Today 8hr
    according to regional regulatory guidance and internal standards Manage the creation and submission of regulatory dossiers across regions… deliverables to support a Global Regulatory Filing. The manger will manage and deliver every submission every time. Key responsibilities…
  • 4.8
    Jounce Therapeutics – Cambridge, MA
    Est. Salary $114k-$161k
    22 days ago 22d
    create innovative regulatory strategies for targeted biologics to treat cancer. Furthermore, the RA Senior Manager will represent… global regulatory strategies for assigned programs and working with the regulatory team on execution. Represents regulatory affairs…
  • 4.4
    Advanced Clinical – Princeton, NJ
    Est. Salary $88k-$128k
    1 days ago 21hr
    opportunity for a Senior Manager Regulatory Strategy located in Princeton, New Jersey. This role will provide regulatory expertise and… level Determines regulatory requirements for clinical and pre-clinical submissions to Assures that Regulatory Affairs is adequately…
  • 3.4
    Teva Pharmaceuticals – Parsippany, NJ
    1 days ago 17hr
    technically competent regulatory submissions. Publish and dispatch complex routine/lifecycle management eCTD submission projects Troubleshoot… publishing and quality control checks of submissions. Participate in Global Regulatory Affairs project teams Maintain working…
  • 2.8
    NantWorks – Culver City, CA
    17 days ago 17d
    Position Overview: The Senior Manager, Regulatory Writing is a full-time, Culver City, CA office-based position. The incumbent… bodies. Provide documents that are suitable for eCTD regulatory submissions, by conducting appropriate formatting and hyperlinking…
  • 4.2
    Agios Pharmaceuticals – Cambridge, MA
    Est. Salary $118k-$165k
    19 days ago 19d
    Apply Now Job Brief Senior Manager, Regulatory Affairs Senior Manager, Regulatory Affairs Agios (agios.… Senior Manager, Regulatory Affairs Location Agios Pharmaceuticals HQ Job Code 386 # of openings…
  • 3.9
    Sangamo Therapeutics – Richmond, CA
    Est. Salary $100k-$214k
    21 days ago 21d
    Director/Senior Director, Regulatory Affairs Manager: Vice President, Regulatory Affairs Department: Regulatory Affairs… prepare, and review regulatory documentation and ensure data and conclusions are suitable for submission to regulatory agencies.…
  • 3.7
    bluebird bio – Cambridge, MA
    24 days ago 24d
    cGxP approved documentation. Manage the data integrity (QC) program to ensure data in regulatory filings has been verified against… include Quality review of all regulatory filings, coordination of Quality responses to regulatory authorities, and key member of…
  • 4.2
    Agios Pharmaceuticals – Cambridge, MA
    Est. Salary $103k-$175k
    18 days ago 18d
    vendor Manage submission components as necessary within the eDMS Track document preparation and timelines with Regulatory Affairs… Senior Associate/Manager, Regulatory Operations Location Agios Pharmaceuticals HQ Job Code 441…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $129k-$177k
    1 days ago 1d
    Duties and Responsibilities: Develop and manage regulatory submissions such as 510(k), Investigational Device Exemptions… to define contributions to submissions for regulatory submissions. Interface with global regulatory authorities, strategic partner…
  • 4.0
    KAISER – Portland, OR
    6 days ago 6d
    quarterly HHS submissions. - Regulatory Advocacy. Coordinate internal and community stakeholder's comments to proposed regulatory rules… The Regulatory QHP Coordinator (RQC) is responsible for the coordination, completion and submission of QHP binder filings for…
  • 4.8
    AirXpanders – Palo Alto, CA
    Est. Salary $77k-$115k
    17 days ago 17d
    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…
  • 3.6
    PRA Health Sciences – Boston, MA
    Est. Salary $90k-$128k
    1 days ago 14hr
    including Alliance Partners. Plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical… As a Senior Manager, Regulatory Strategy CMC, you will develops and leads the execution of regulatory CMC development and registration…
  • 1.9
    Pharmacyclics – Sunnyvale, CA
    Est. Salary $130k-$197k
    3 days ago 3d
    trains others to conduct audits of clinical study and regulatory submission documents, including , Clinical Study Reports, Trial… applicable • Manages contractors/consultants, and may manage other CQA employees • Facilitates regulatory authority inspection…
  • 4.4
    Advanced Clinical – Framingham, MA
    Est. Salary $53k-$78k
    Today 11hr
    consults on regulatory project needs and is responsible for developing required regulatory documentation and submissions Provides… post-approval change control assessments and submissions Coordinates and prepares regulatory document packages to support post-market…
  • 4.4
    Advanced Clinical – Princeton, NJ
    Est. Salary $105k-$155k
    1 days ago 21hr
    Division Director level Determines regulatory requirements for clinical and pre-clinical submissions to FDA for assigned investigational… Management and Development, Program Management and Regulatory Submissions Develops strategies, drafts responses, or reviews…
  • Randstad Life Sciences – Westborough, MA
    2 days ago 2d
    consults on regulatory project needs and is responsible for developing required regulatory documentation/submissions. Provides direction… the regulatory licenses. Provide regulatory guidance and strategy Responsible for drafting and finalizing CMC submission with…
  • 2.5
    Glenmark Pharmaceuticals Inc. – Mahwah, NJ
    Est. Salary $77k-$116k
    8 days ago 8d
    terms of data collection and presentation to support regulatory dossier submission. Key Responsibilities: Perform Oversight… Clinical Science, Pharmacology, Data Management, Biostatistics, Regulatory Affairs, …) Other Data Management related tasks assigned…
  • Advanced Clinical Holdings – Princeton, NJ
    Est. Salary $83k-$121k
    1 days ago 15hr
    opportunity for a Senior Manager Regulatory Strategy located in Princeton, New Jersey. This role will provide regulatory expertise and… OVERVIEW Are you a Senior Manager Regulatory Strategy professional with five years of experience? Our client has an amazing…
  • Merchants Bank VT – Burlington, VT
    9 days ago 9d
    accounting principals and within regulatory guidelines. Additionally, the Controller ensures the Bank's Senior Management team and business… Marketing Manager, South Burlington, VT At Merchants Bank, the Marketing Manager proactively partners with Senior leadership…
  • 3.7
    bluebird bio – Cambridge, MA
    Est. Salary $117k-$138k
    10 days ago 10d
    sections and interpretation of the study results Support regulatory submissions as needed Support the preparation of publications,… statistical efforts for multiple clinical studies. The Sr. Manager, Biostatistics role will be responsible for overseeing statistical…
  • 3.5
    Evoke Health – New York, NY
    Today 6hr
    expert in our clients’ Medical/Legal/Regulatory review processes and ensures clean submissions with previous learnings applied… aids junior account management team members and supports the senior level Account team in building strong, mutually trusting relationships…
  • 3.0
    Moderna Therapeutics – Cambridge, MA
    Est. Salary $137k-$315k
    3 days ago 3d
    materials for regulatory compliance. Partners with internal teams and Moderna partners to develop content and manage submissions to regulatory… Responsibilities Develops content, format and accountability for regulatory submissions and related supplements and amendments. Advises project…
  • 2.8
    Neighborhood Health Plan – Somerville, MA
    Est. Salary $101k-$150k
    13 days ago 13d
    SERFF plan and benefits templates, if applicable Manage Planfinder submissions Serve as NHP’s primary lead and/or participate… Reporting to the Manager, Product Operations, the Senior Product Manager (SPM) is responsible for managing the product portfolio…
  • 3.5
    Evoke Health – New York, NY
    Today 6hr
    expert in our clients’ Medical/Legal/Regulatory review processes and ensures clean submissions with previous learnings applied… meaningful relationships at the senior level Expands the client relationship beyond the product manager and beyond marketing Leads…
  • 3.9
    Sangamo Therapeutics – Richmond, CA
    Est. Salary $95k-$147k
    2 days ago 2d
    in-house QC department Assist in the preparation of CMC regulatory submissions Other activities as may be assigned EDUCATION… for biologic products Experience of assays methods and regulatory/pharmacopeia requirements for biologic products…
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