Regulatory Submissions Manager Jobs | Glassdoor
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Regulatory Submissions Manager Jobs

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  • 3.1
    Moderna Therapeutics – Cambridge, MA
    Est. Salary $125k-$288k
    21 days ago 21d
    materials for regulatory compliance. Partners with internal teams and Moderna partners to develop content and managesubmissions to regulatory… Responsibilities Develops content, format and accountability for regulatorysubmissions and related supplements and amendments. Advises project…
  • Advanced Clinical Holdings – Cambridge, MA
    4 days ago 4d
    the Global Regulatory Lead, as manager of cross-functional submission team, will plan and manageregulatorysubmissions and author… process and evidence of working with Regulatory Agencies supporting regulatory dossier submission, review and approval processes…
  • 4.0
    TechData Service Company, LLC – Princeton, NJ
    Est. Salary $68k-$117k
    NEW
    Manageregulatorysubmissions such as IND, NDA, sNDA, etc., in US Organize and prepare for various types of regulatory… etc. Provide regulatory guidance for clinical research and commercial development Ensure regulatorysubmission is compliant…
  • 4.0
    ResMed – San Diego, CA
    Est. Salary $50k-$78k
    NEW
    to the Sr. Manager, Regulatory Affairs. Responsibilities: Execute US and international regulatorysubmissions to ensure timelines… execute regulatory strategies. Be willing to work with a Lean team and wear multiple hats for regulatorysubmissions and an expanding…
  • 3.7
    Hologic – Marlborough, MA
    Est. Salary $75k-$107k
    28 days ago 28d
    review process by reviewing documents for regulatory compliance Prepares FDA submissions, which may include: 510(k)s, IDEs, IDE… Medical device software submission and validation experience highly desirable Certified regulatory affairs professional highly…
  • 3.6
    Otsuka America Pharmaceutical – Princeton, NJ
    Est. Salary $95k-$134k
    11 days ago 11d
    Clinical/Regulatory Teams (CRTs), Global Regulatory Teams (GRTs), Submission teams and Lead CMC GRTs, and Submission CMC subteams… documents/labels and labeling for submission to regulatory authorities to assure compliance with regulatory standards and scientific/technical…
  • 2.9
    SonoSite – Bothell, WA
    Est. Salary $57k-$82k
    NEW
    coordinating and executing Class II regulatorysubmissions to various international regulatory agencies, including FDA (510(k)),… Responsibilities: Coordinate and prepare product submission packages for regulatory agencies (U.S. and major International markets…
  • 3.5
    EMD Serono – Billerica, MA
    Est. Salary $154k-$209k
    19 days ago 19d
    top regulatory quality across all Health Authority regulatorysubmissions and planning for production of dossier(s).Manage the… successful submission and approval of clinical trials, marketing authorizations as well as other strategic regulatorysubmissions (e.g…
  • 2.9
    Worldwide Clinical Trials – Morrisville, NC
    Est. Salary $63k-$92k
    16 days ago 16d
    Vacancy Name Freelance Medical Writer (IND Submissions)~Home based, US Vacancy No VN384 Employment Type Contract Location… written, scientific, and ethical standards in accordance with regulatory requirements and WCT standard operating procedures (SOPs).…
  • 3.6
    Novo Nordisk – Washington, DC
    NEW
    excellence. Plan and manage interactions with NNI and NN A/S regulatory management and liaison staff for submission of product applications… initiatives impacting the FDA. Manage interactions and communications with FDA on regulatory policy matters. Maintain liaison…
  • 3.7
    Pfizer – Groton, MA
    Est. Salary $81k-$117k
    4 days ago 4d
    corporate policies governing documents for regulatorysubmission. Provide project teams with expertise and strategic guidance on analysis… of and ability to interpret regulatory guidance's in context of specific products and submission documents. Ability to synthesize…
  • 3.5
    EMD Serono – Billerica, MA
    Est. Salary $154k-$209k
    25 days ago 25d
    input from all regulatory functions and regions. Drive and manage the production of top quality submissions dossier(s) in cooperation… Ensure top quality across all regulatorysubmissions. Plan for production of dossier(s) with the required content and quality…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    Est. Salary $49k-$108k
    5 days ago 5d
    to case management and related activities. Oversees timely submissions of expedited reports to the FDA & other health authorities… of the pharmacovigilance system and adheres to all global regulatory requirements and internal processes and procedures. The qualified…
  • 4.5
    Advanced Clinical – Hampton, NJ
    Est. Salary $123k-$166k
    12 days ago 12d
    into operational deliverables (i.e. submissions) Assesses and communicates device regulatory requirements to ensure development… compliance with applicable regulations and guidelines Managesregulatory activities in respect to quality and timeliness Interacts…
  • 3.7
    Pfizer – New York, NY
    Est. Salary $112k-$168k
    NEW
    the CD&O deliverables for a submission. Including inspection readiness, submission and regulatory defense. The CPM is an expert… The Clinical Project Manager (CPM) will lead and manage the core cross functional study team (or submission sub-teams) and is the…
  • 2.5
    Medpace, Inc. – Cincinnati, OH
    Est. Salary $89k-$159k
    NEW
    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…
  • 3.6
    Medtronic Inc. – Mansfield, MA
    Est. Salary $70k-$93k
    NEW
    from worldwide regulatory bodies. Working with global Regulatory Affairs colleagues, you will ensure submissions are accurately… projects, change assessment, domestic submissions, international submissions, commercial support, manufacturing support, compliance…
  • 4.5
    Advanced Clinical – Abbott Park, IL
    Est. Salary $45k-$66k
    5 days ago 5d
    with multiple departments, as appropriate, involved in regulatorysubmissions Receiving documents from various sources and review… as needed Reviewing regulatory documents to assure FDA requirements are met and are ready for submission Responsible to handle…
  • 3.6
    Medtronic Inc. – North Haven, CT
    Est. Salary $52k-$69k
    Today 3hr
    to be included in 510(k) submissions and clinical evaluation reports. Add and maintain regulatory information of internal shared… managementsystems. The Associate Regulatory Affairs Specialist must demonstrate thefollowing behaviors: Manage multiple projects and…
  • 3.6
    Sysmex America – Mundelein, IL
    17 days ago 17d
    Knowledge of global clinical trials for IVD regulatorysubmissions and submission requirements. Sysmex is proud to be an EEO… IVDR and global regulatory registrations including strategic development for future US FDA Class III, PMA submission. Other responsibilities…
  • Axovant Sciences – New York, NY
    Est. Salary $66k-$153k
    NEW
    budgets. Proactively identifies and manages issues and opportunities related to NDA submissions; ensures appropriate communication… efficient project plan for a NDA submission Identifies emerging changes related to the submission project and implements strategies…
  • 3.3
    Baxter – Saint Paul, MN
    Est. Salary $77k-$118k
    14 days ago 14d
    support for major market regulatory approvals. He/She will manage product and/or product family submissions concurrently in several… provide strategic regulatory guidance and review Prepare core dossier/STED for U.S. and international submissions for products with…
  • 3.1
    Bausch & Lomb – Bridgewater, NJ
    Est. Salary $65k-$97k
    NEW
    brand products. Supports the Regulatory Affairs Senior Manager for Brand and Generic submission timelines and liaises with the… Pharmaceutical Regulatory Brand Senior Manager to make certain all product documentation is developed in accordance with regulatory requirements…
  • 3.7
    Horizon Pharma – Lake Forest, IL
    Est. Salary $110k-$182k
    27 days ago 27d
    Oversee project submission timelines, schedules and regulatorysubmission processes Lead compliant submissions for FDA and Health… production of regulatorysubmissions. Assists in providing development, implementation and maintenance of processes for submissions.…
  • 2.9
    State of Florida – Tallahassee, FL
    Today 3hr
    Preference must attach supporting documentation with each submission that includes character of service (for example, DD Form 214… Business and Professional Regulations Working Title: REGULATORY SPECIALIST II - DBPR-DSO-Internal Agency Position Number…
  • 4.0
    Tesaro – Waltham, MA
    Est. Salary $109k-$145k
    7 days ago 7d
    • Experience in preparation and submission of CMC documents in support of regulatory filings. • Demonstrate project management… development plans, and international product registration submissions. Follows up with deliverables on action items. Records decisions…
  • 3.8
    Veeva Systems – United States
    Today 11hr
    FirstDoc/FirstPoint, NextDocs, CARA, other regulatory information management or submission publishing systems, etc. Life Science,… who have deep regulatory expertise and a passion for helping customers transform the way they manage their regulatory information…
  • 3.9
    NYU Langone Medical Center – New York, NY
    12 days ago 12d
    international regulatory requirements and current practice standards for clinical trials including regulatorysubmissions Train… Consult on the effort and budget required for regulatory activities in the submission of funding proposals Maintain up-to-date…
  • 2.9
    State of Florida – Panama City Beach, FL
    Today 3hr
    Preference must attach supporting documentation with each submission that includes character of service (for example, DD Form 214… Business and Professional Regulations Working Title: Regulatory Specialist I - DBPR/Hotels and Restaurants OPEN COMPETITIVE…
  • 3.5
    Novozymes – Franklinton, NC
    NEW
    approvals, assisting in the preparation of regulatorysubmissions to US and Canadian regulatory agencies. You will research, review and… the world and the way people live and work. Regulatory Associate/Regulatory Specialist As a world leader in biotechnology…
  • 2.3
    Fresenius Kabi USA – Lake Zurich, IL
    6 days ago 6d
    maintenance of regulatory dossiers. Interacts with project teams and regulatory agencies in relation to submissions and other relevant… requirements Preparing and filing high-quality submissions to regulatory authorities (A/NDA’s, Supplements, Amendments, Annual…
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