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Regulatory Jobs

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  • 4.4
    CIVCO Radiotherapy – Coralville, IA
    13 days ago 13d
    , creativity, and energy. The Regulatory Specialist is responsible for supporting Regulatory initiatives in the areas of global… following. (Other duties may be assigned.) Regulatory Administration: Support regulatory approvals for change orders, deviations…
  • 2.9
    Natera – San Carlos, CA
    Est. Salary $65k-$96k
    7 days ago 7d
    FDA and other regulatory agencies. Provides risk assessments and regulatory options. Prepares U.S. regulatory submissions… POSITION SUMMARY The Regulatory Affairs Specialist will be responsible for the preparation of regulatory submissions required…
  • 2.4
    Fresenius Kabi USA – Lake Zurich, IL
    10 days ago 10d
    Manager or Director of Regulatory Affairs. Responsible for the on-time filing of high-quality regulatory submissions and for post-approval… post-approval maintenance of regulatory dossiers. Interacts with project teams and regulatory agencies in relation to submissions…
  • 3.6
    Foundation Medicine – Cambridge, MA
    Est. Salary $63k-$94k
    4 days ago 4d
    Co-development regulatory projects. This role will have the unique opportunity to contribute to the development of regulatory submissions… diagnostics Experience with regulatory submissions [PMA, IDE, 510(k)] with a manufacturer or in a regulatory consulting role PhD preferred…
  • 3.3
    Shire Pharmaceuticals LLC – Cambridge, MA
    Est. Salary $141k-$192k
    18 days ago 18d
    contact and accountability for regulatory and leads the regulatory subteams as well as represents regulatory on key internal decision… group of regulators as part of Global Regulatory Functions as the global regulatory lead for assigned projects, working with…
  • 3.4
    Baxter – Round Lake, IL
    Est. Salary $70k-$97k
    19 days ago 19d
    Compile and submit, in a timely manner, regulatory documents according to regulatory requirements for globally licensed biologic… protocols and studies required to support regulatory submissions. 3) Provide regulatory advice to various stakeholders including…
  • 4.0
    Hypertherm – Hanover, NH
    26 days ago 26d
    We are looking for a Global Regulatory Engineering Leader at our 100% employee-owned manufacturing company headquartered in… formal and informal channels to define and execute our product regulatory strategy, ensuring that it is aligned with Hypertherm’s business…
  • 3.7
    BioMerieux – Saint Louis, MO
    Est. Salary $41k-$69k
    5 days ago 5d
    Assist in the execution and improvement of regulatory processes, interactions with regulatory agencies, participate and support audits… Regulatory & Quality Compliance Specialist - 44977 Description A strong Scientific and technological pioneering…
  • 2.7
    Afni – Bloomington, IL
    3 days ago 3d
    Afni is hiring a Regulatory Lead who will be responsible for leadership of the regulatory portion of the compliance department… Management: Leadership and development responsibilities for the regulatory portion of the compliance department. This includes support…
  • 2.5
    FibroGen – San Francisco, CA
    6 days ago 6d
    directly with the Director of Regulatory Operations Department . The intern will be exposed to the Regulatory Operations role including… information in support of regulatory submissions for our drug products. Gaining exposure to the Regulatory Archiving process.…
  • 4.4
    Advanced Clinical – Lake Forest, IL
    Est. Salary $48k-$70k
    10 days ago 10d
    well-known client’s team as a Regulatory Affairs Manager in Lake Forest, Illinois. The Regulatory Affairs Manager is responsible… and determine regulatory impact A minimum of three years of work experience Experience in post-market regulatory tasks Strong…
  • 3.2
    Sutro Biopharma – South San Francisco, CA
    EASY APPLY
    Est. Salary $75k-$114k
    3 days ago 3d
    fast paced environment. The Regulatory Operations Manager will assist with Regulatory submission projects including managing… s). The Regulatory Operations Manager will be responsible for tracking submission documents between authors, Regulatory affairs…
  • 4.9
    Prospect 33 – Morrisville, NC
    Est. Salary $52k-$87k
    3 days ago 3d
    definition and scope of the regulatory program and ensure these requirements enable the IBs regulatory compliance and align to the… Raleigh, NC is looking for a Project Manager to join the Regulatory Reference Data team. The Project Manager is expected to…
  • 3.3
    Shire Pharmaceuticals LLC – Cambridge, MA
    Est. Salary $84k-$126k
    4 days ago 4d
    sections of regulatory submissions and interactions with regulatory agencies. 25% Develop global CMC regulatory strategy for… Under the direction of the Director of Regulatory Affairs direct and manage Regulatory Affairs activities for developing global…
  • 3.3
    Shire Pharmaceuticals LLC – Westlake Village, Los Angeles, CA
    17 days ago 17d
    planning, publishing (paper, NeES, eCTD), review and dispatch of regulatory submissions to global Health Authorities within required timeframes… upgraded software. Responsibilities: 75%:  Plan and publish regulatory submissions, ensuring timely submission of high quality, compliant…
  • 3.2
    T2 Biosystems – Lexington, MA
    Est. Salary $61k-$90k
    13 days ago 13d
    current regulatory knowledge and keep up to date with regulatory procedures and changes identifying critical regulatory/compliance… our team as a Senior Regulatory Affairs Specialist. Summary: As a member of the Clinical and Regulatory team you will be responsible…
  • 3.7
    BioMerieux – Saint Louis, MO
    Est. Salary $50k-$75k
    12 days ago 12d
    implementation of regulatory procedures. Manages communication with regulatory agencies and notified body on regulatory procedures.… including required responses to regulatory agencies. Provides technical support and guidance to Regulatory Affairs team in charge of…
  • 3.7
    Rangam Consultants – Westborough, MA
    Est. Salary $59k-$89k
    12 days ago 12d
    supporting the on-time submission of regulatory submissions. Additional duties may include regulatory compliance administrative support… The following job responsibilities: Perform general Regulatory Affairs Chemistry Manufacturing and Controls (CMC) work including…
  • 3.7
    Sysmex America – Mundelein, IL
    Est. Salary $71k-$125k
    26 days ago 26d
    a great opportunity available for a Regulatory Affairs Senior Specialist. The Regulatory Affairs Senior Specialist will combine… Sheets (SDS) & labels compliant with global regulatory requirements or changes to regulatory requirements. 2. Contribute to the development…
  • 2.5
    FibroGen – San Francisco, CA
    Est. Salary $100k-$142k
    6 days ago 6d
    a Senior Manager of Regulatory Affairs, the Associate/Senior Associate will support day-to-day regulatory activities of assigned… compilation of submissions for regulatory agencies, assigned clinical studies, management of regulatory submissions processes and timelines…
  • 2.8
    The Natures Bounty Co – Ronkonkoma, NY
    3 days ago 3d
    easily available anywhere they shop. Job Description The Regulatory Specialist develops label manuscripts containing all information… Federal Regulations (CFR) and other applicable regulations, the Regulatory Specialist ensures label manuscripts and proofs are prepared…
  • 3.3
    Shire Pharmaceuticals LLC – Cambridge, MA
    3 days ago 3d
    optimal regional regulatory strategies, and iii) Responsible for the effective management and execution of regulatory filings. Key… relationships with regulatory agencies to ensure a positive company image, as well as providing technical and procedural regulatory guidance…
  • 3.7
    Two95 International Inc. – San Diego, CA
    EASY APPLY
    7 days ago 7d
    Title: Regulatory Submission Specialist Location: San Diego, CA Duration: 6 months Start: November 7th Interview: Phone…
  • 2.8
    Grifols – Los Angeles, CA
    Est. Salary $57k-$84k
    5 days ago 5d
    and maintain Regulatory Submission Documentation for global regulatory submissions. Compile and submit regulatory documentation… submission to regulatory Prepare official submissions to regulatory agencies for new or modified products. Compile regulatory submissions…
  • 2.8
    The Natures Bounty Co – Ronkonkoma, NY
    3 days ago 3d
    or Nutrition Facts panel. The Senior Regulatory Specialist will assign work to Regulatory Specialists and review their work for… requirements. • Assigns work to Regulatory Specialists. Participates in review of Regulatory Specialist work and has approval…
  • Randstad Life Sciences – Marlborough, MA
    5 days ago 5d
    Title: Regulatory Affairs Specialist Position Description Responsible for domestic and international regulatory activities… new product development teams to coordinate preparation of regulatory content for domestic and international submissions for IVD…
  • 3.8
    Stem Inc – Millbrae, CA
    Est. Salary $106k-$154k
    12 days ago 12d
    proposals, analyzing and regulatory and legislative documents, and drafting and winning on regulatory submissions Representation… providers and consumers. Position Summary The Senior Manager Regulatory Affairs, West will lead Stem’s policy and political representation…
  • 3.1
    United Health Services Hospitals – Binghamton, NY
    Est. Salary $45k-$63k
    3 days ago 3d
    DIFFERENCE. UHS Hospitals Located in Binghamton, NY Clinical Regulatory Analyst Under general direction or assignment serves as a… development and implementation of these systems. Analyze regulatory requirements as related to IT and services as liaison between…
  • 4.8
    Jounce Therapeutics – Cambridge, MA
    Est. Salary $115k-$162k
    18 days ago 18d
    global regulatory strategies for assigned programs and working with the regulatory team on execution. Represents regulatory affairs… programs. Educates company on regulatory requirements and evolving trends and disseminates regulatory intelligence relevant to the…
  • RaNA Therapeutics – Cambridge, MA
    EASY APPLY
    Est. Salary $62k-$140k
    12 days ago 12d
    developing and directing global regulatory strategy; planning, overseeing and delivering all regulatory filings; and managing all interactions… and meetings with regulatory agencies. Primary Responsibilities Develop and direct the global regulatory strategy and objectives…
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