Senior regulatory submissions manager Jobs in Philadelphia, PA | Glassdoor
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Senior regulatory submissions manager Jobs in Philadelphia, PA

75 Jobs

  • 3.5
    Scientific Search – Philadelphia, PA
    $60k-$88k(Glassdoor est.)
    NEW
    controlled documents for conformance to regulatory requirements. The SeniorRegulatory Affairs Associate will be expected to share… regulations and guidances. Will assist in determining regulatory strategy for new submissions and post-approval changes. The candidate will…
  • 3.4
    Exponent – Philadelphia, PA
    $136k-$216k(Glassdoor est.)
    5 days ago 5d
    FDA regulatory environments Demonstrated experience in working with FDA and successful completion of 510(k) submissions and… Biomedical Engineering Practice is currently hiring for a RegulatorySenior Managing/Principal Engineer in our United States offices…
  • 3.7
    Veeva Systems – Philadelphia, PA
    11 days ago 11d
    helping customers transform the way they manage their regulatory information, submission content and archives in the cloud. As… FirstDoc/FirstPoint, NextDocs, CARA, other regulatory information management or submission publishing systems, etc. Life Science,…
  • 3.7
    GlaxoSmithKline – Philadelphia, PA
    7 days ago 7d
    and timely review of advisory submissions and effective resolution of regulatory actions. Manage interaction with OPDP including… response to regulatory inquiries or enforcement actions, preparation of complete, accurate, high quality submissions for advisory…
  • 4.0
    Jazz Pharmaceuticals – Philadelphia, PA
    $107k-$151k(Glassdoor est.)
    14 days ago 14d
    Coordinate the preparation and timely submission of responses to regulatory agencies. Manage timelines to ensure approvals are timely… The SeniorManager, Regulatory Affairs Global CMC will be responsible for managing registration and CMC regulatory support…
  • 3.3
    Teva Pharmaceuticals – Frazer, PA
    NEW
    of accurate, timely and technically competent regulatorysubmissions. Responsibilities Build and dispatch lifecycle management… issues with Adobe Acrobat & MS Word3. Manage technical aspects for assigned submissions and status updates to concerned parties…
  • 3.8
    Pfizer – Collegeville, PA
    $97k-$138k(Glassdoor est.)
    NEW
    of regulatorysubmissions (NDAs and MAAs). Able to interpret complex analyses of data supporting regulatorysubmissions Ability… corporate policies governing documents for regulatorysubmission. Provide project teams with expertise and strategic guidance on analysis…
  • 3.7
    Two95 International Inc. – Philadelphia, PA
    EASY APPLY
    19 days ago 19d
    Title: Regulatory Affairs Manager Location: Philadelphia, PA Duration: 6 month C2H Interview: Phone & F2F Start: 12… experience with submission-related FDA regulations and guidelines for both paper and electronic (eCTD) submissions Excellent communication…
  • 2.1
    Lannett – Philadelphia, PA
    $63k-$95k(Glassdoor est.)
    5 days ago 5d
    guidances. The applicant will assist in determining regulatory strategy for new submissions and post-approval changes. The applicant will… controlled documents for conformance to regulatory requirements. The SeniorRegulatory Affairs Associate will be expected to share…
  • 4.2
    University of Pennsylvania – Philadelphia, PA
    $39k-$59k(Glassdoor est.)
    NEW
    gene therapy research studies, and the management of regulatorysubmissions and resource management. Facilitates interdisciplinary… human application. Reporting to the Senior Director (SD), PMC, the Core Program Manager (CPM) has overall responsibility for…
  • 4.5
    Advanced Clinical – King of Prussia, PA
    4 days ago 4d
    reports, regulatorysubmissions, abstracts, posters, presentations, peer reviewed manuscripts, and other documents Manage the processes… being conversant in regulatory guidelines and clinical terminology. Organized. You’re an efficient time-manager and can handle…
  • 2.9
    FMC Corporation – Philadelphia, PA
    14 days ago 14d
    competitive and/or regulatory pressure. Effectively manage unplanned events that affect quality of submissions and budgets. Provide… requires a full understanding of the regulatory and legislative initiatives that shape the regulatory environment for the industry.…
  • 4.2
    University of Pennsylvania – Philadelphia, PA
    $47k-$67k(Glassdoor est.)
    24 days ago 24d
    aggressively manage events that may affect timeline milestones and projected budgets), and work with Director of Regulatory Affairs… managing related submission timelines. For each Project Team, PM will coordinate timely preparation and submission of technical progress…
  • 3.3
    Towers Watson – Philadelphia, PA
    $46k-$66k(Glassdoor est.)
    9 days ago 9d
    agencies. The Role The Senior Accountant – SEC Reporting, under the direction of the Manager of SEC Reporting and the Director… organization. Resumes must be submitted according to our candidate submission process, which includes being actively engaged on the particular…
  • 3.2
    Digitas Health – Philadelphia, PA
    $88k-$118k(Glassdoor est.)
    22 days ago 22d
    communications Annotate references and create reference submission decks Verbally sell, debate, or support your research internally… blast. You need to navigate the intricacies of the body, regulatory rules and complex treatment categories with equal aplomb one…
  • 3.3
    Willis Towers Watson – Philadelphia, PA
    8 days ago 8d
    organization. Resumes must be submitted according to our candidate submission process, which includes being actively engaged on the particular… authorized Recruitment Agencies/Search Firms, if the candidate submission process is not followed, no agency fees will be paid by Willis…
  • 3.6
    Reed Smith – Philadelphia, PA
    $42k-$64k(Glassdoor est.)
    24 days ago 24d
    studies, bios etc.). If needed, assist with directory submissions (Chambers, Legal 500, etc.) to ensure marquee practice areas… multi-jurisdictional and other high-stakes matters; deliver regulatory counsel; and execute the full range of strategic domestic…
  • 4.2
    University of Pennsylvania – Philadelphia, PA
    $47k-$67k(Glassdoor est.)
    17 days ago 17d
    aggressively manage events that may affect timeline milestones and projected budgets), and work with Director of Regulatory Affairs… managing related submission timelines. For each Project Team, PM will coordinate timely preparation and submission of technical progress…
  • 3.1
    Premier Research – Philadelphia, PA
    $146k-$231k(Glassdoor est.)
    15 days ago 15d
    study design, investigator brochure development, regulatory strategy and submission, and study execution strategies Liaises with… Biometrics. Provides consultation with project teams (and/or other senior personnel) to assist client management and communication Offers…
  • 3.6
    Merck – Gwynedd, PA
    23 days ago 23d
    serious diseases. The Regulatory Affairs International Headquarters (RAI HQ) Senior Scientist, Regulatory Liaison position in the… 2017 Location: Gwynedd, PA, US Company: MSD Senior Scientist, Regulatory Liaison-REG****** Description Merck & Co…
  • 4.0
    Axelon, Inc. – Horsham, PA
    $60k-$91k(Glassdoor est.)
    8 days ago 8d
    submits high quality, regulatorysubmissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable… appropriate regulatorysubmissions (ANDA supplements, deficiency responses, and Annual Reports) for FDA submissions within a specified…
  • 3.1
    Premier Research – Philadelphia, PA
    $146k-$231k(Glassdoor est.)
    15 days ago 15d
    study design, investigator brochure development, regulatory strategy and submission, and study execution strategies. Liaises with… Biometrics. Provides consultation with project teams (and/or other senior personnel) to assist client management and communication. Offers…
  • 4.0
    Johnson & Johnson – Fort Washington, PA
    $158k-$210k(Glassdoor est.)
    10 days ago 10d
    others to develop regulatory strategies for submissions and product related activities. Negotiate with regulatory agencies to establish… leaders to refine/develop processes relating to regulatorysubmissions and regulatory aspects of product development. Train and…
  • 3.3
    Teva Pharmaceuticals – Frazer, PA
    $123k-$168k(Glassdoor est.)
    NEW
    with (Sr. Manager) Health Authority project managers and CMC reviewers to facilitate approval of regulatorysubmissions and coordinates… support of marketed product registrations. The SeniorManager CMC, Regulatory Affairs (Specialty Products - Biologics/Biosimilars…
  • 4.4
    Ascent Services Group – Fort Washington, PA
    20 days ago 20d
    global label development and worldwide submissions and approvals. Utilize regulatory, labeling and project management expertise… Global Regulatory Affairs Labeling Lead - REMOTE OKAY Remote Contract (1 year) **5+ years of experience in Regulatory Labeling…
  • 3.0
    TechUSA – Malvern, PA
    18 days ago 18d
    international regulatory requirements are incorporated as part of the development process -Author submissions and other regulatory documents… FDA and other regulatory agencies on submissions, approvals or other issues -Establish and maintain regulatory information systems…
  • 3.6
    Merck & Co., Inc. – West Point, PA
    NEW
    responsible for the support of formulation development and regulatorysubmissions. Your main responsibilities, which are in no particular… authoring IND, IMPD, and/or NDA/WMA submissions. (US/Puerto Rico Only) In accordance with Managers' Policy - Job Posting and Employee…
  • 4.1
    Incyte Corporation – Wilmington, DE
    $120k-$168k(Glassdoor est.)
    30+ days ago 30d+
    SeniorManager, Regulatory Affairs CMC This position will primarily be responsible for managing regulatory CMC submissions and… maintained. In alignment with RA-CMC leader, manageregulatory CMC strategy and submission aspects for both small and large molecule…
  • 3.6
    Certara – Malvern, PA
    17 days ago 17d
    to efficiently manage and publish, validate and review eCTD submissions. Regulatory Services - submission and publishing services… disclosure requirements. Submission Management - our suite of products consists of solutions regulatory operations professionals…
  • 3.2
    CSL Behring – King of Prussia, PA
    8 days ago 8d
    Prioritization of global regulatorysubmissions based on team input Responsible for development of core regulatory position and documentation… documents. Present regulatory plans, risk assessments and strategies, pertaining to the assigned project(s), to senior review committees…
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