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Senior regulatory submissions manager Jobs

1,621 Jobs

  • Conventus BioMedical Solutions – San Diego, CA
    EASY APPLY
    $156k-$209k(Glassdoor est.)
    25 days ago 25d
    target product profile (TPP) Submission Management: Manage preparation of regulatorysubmissions, including maintaining timelines… environment, the Regulatory Affaires SeniorManager or Associate Director will be responsible for executing regulatory strategy as…
  • 2.7
    Shire – Cambridge, MA
    11 days ago 11d
    The RegulatorySeniorSubmission Specialist is responsible for the planning, publishing (paper, NeES, eCTD), review and delivery… regulatory guidelines to produce regulatorysubmission business requirements and ensure that those requirements are implemented…
  • 3.9
    Tesaro – Waltham, MA
    $114k-$155k(Glassdoor est.)
    HOT
    • Experience in preparation and submission of CMC documents in support of regulatory filings. • Demonstrate project management… SeniorManager, CMC PM Company/Position Description TESARO is an oncology-focused biopharmaceutical company dedicated…
  • 4.4
    bluebird bio – Cambridge, MA
    EASY APPLY
    $102k-$144k(Glassdoor est.)
    25 days ago 25d
    represent the function of regulatory CMC on project teams and will oversee regulatory CMC submissions across projects. About… rare diseases Lead the regulatory CMC team to successfully file high-quality regulatory CMC submissions prepared in collaboration…
  • 3.6
    Merck – Rahway, NJ
    $117k-$162k(Glassdoor est.)
    4 days ago 4d
    serious diseases. Senior Specialist, RegulatorySubmissionManagerRegulatory Portfolio and Submissions Management works closely… timely/regulatorysubmissions. The position will be responsible for independently managing regulatory and safety submission projects…
  • 3.7
    Shockwave Medical – Fremont, CA
    EASY APPLY
    $85k-$122k(Glassdoor est.)
    HOT
    Participate in the design and execution of global studies for regulatorysubmissions, reimbursement and product adoption, including clinical… implementation and data management. Manage study preparation, activation, enrollment, submission, maintenance and closure activities…
  • 4.2
    Nanostring Technologies – Seattle, WA
    EASY APPLY
    $113k-$160k(Glassdoor est.)
    16 days ago 16d
    support multiple projects Proven ability to prepare regulatorysubmissions and interact with FDA to obtain and maintain product… certifications, and alignment of regulatory strategy with corporate strategy in conjunction with senior management. Essential Duties…
  • 3.1
    Gilead Sciences – Foster City, CA
    NEW
    complex regulatory CMC submissions in support of clinical and commercial applications Assure regulatorysubmissions are in line… functional groups as well as Regulatory Affairs to plan and produce high quality regulatorysubmissions while meeting aggressive timelines…
  • 3.1
    Gilead Sciences – Foster City, CA
    $122k-$165k(Glassdoor est.)
    NEW
    the preparation of regulatorysubmissions -- which requires interaction with departments outside of Regulatory Affairs -- for investigational… preparation of submissions. Specific Responsibilities and Skills for Position: Responsible for the development of regulatory affairs…
  • 3.1
    Gilead Sciences – Foster City, CA
    $90k-$123k(Glassdoor est.)
    NEW
    coordination of activities via the RegulatorySubmission Team. The Associate Manager in Regulatory Project Management will foster… Under the direction of a seniorRegulatory Project Manager the Associate Manager in Regulatory Project Management will develop…
  • 4.1
    Akebia Therapeutics – Cambridge, MA
    8 days ago 8d
    nonclinical sections for IND, IB, and NDA submissions as well as interactions with regulatory agencies. Excellent interpersonal and… program development plan. Assist in the writing of regulatorysubmissions (INDs, DSURs, IBs, and NDAs). Maintain a current…
  • 3.1
    Santen Inc – Emeryville, CA
    $156k-$205k(Glassdoor est.)
    6 days ago 6d
    Biostatistics, Drug Safety, and Regulatory Affairs to fully understand development programs, regulatory and medical strategies, and… for successful study execution Serves as a liaison for the submission and review of Investigator Sponsored Trials (IST) proposals…
  • 4.1
    Akebia Therapeutics – Cambridge, MA
    $62k-$96k(Glassdoor est.)
    10 days ago 10d
    format conducive to analysis and regulatorysubmissions by working with lead CRO data manager or equivalent Develop/utilize… The Sr. Clinical Data Manager will handle detailed data management issues for all phases of clinical trials (Phase 1-3) including…
  • 3.1
    Sanofi U.S. – Cambridge, MA
    $101k-$146k(Glassdoor est.)
    11 days ago 11d
    include 10 years of Regulatory experience (regional or global) and worldwide experience of regulatorysubmissions and approvals.… ) preparations. Ensure peer review of key regulatory documents and submissions to maintain consistent quality across programs…
  • 3.6
    Sarepta Therapeutics – Cambridge, MA
    $85k-$117k(Glassdoor est.)
    9 days ago 9d
    determine project timelines and ensure senior management review and approval Manageregulatory affairs project meetings, obtain updates… track record with regulatorysubmissions (IND's, CTA's NDAs, CTDs/eCTDs) required Knowledge of regulatory processes, guidelines…
  • 3.6
    Givaudan – New York, NY
    12 days ago 12d
    Regulatory Specialist/Sr Regulatory Specialist As a Regulatory Specialist / SeniorRegulatory Specialist, you will be an integral… Regulatory Expertise – Develop detailed understanding of all applicable regulations, ensure product submissions are in…
  • 3.9
    Tesaro – United States
    $118k-$157k(Glassdoor est.)
    11 days ago 11d
    equivalents). Experience in preparation and submission of CMC documents in support of regulatory filings. Excellent oral and written… contract sites. Working knowledge of regulatory requirements for IND and NDA submissions (or their regional equivalents). Strong…
  • 3.3
    Intarcia Therapeutics, Inc. – Hayward, CA
    $72k-$143k(Glassdoor est.)
    4 days ago 4d
    documents and submissions to regulatory agencies. Partners and aligns with QC stakeholders on content of submissions. Supports… partnering with Regulatory Affairs and QA Change Control to address documentation with regulatorysubmissions. Assists with…
  • 4.0
    Sutro Biopharma – South San Francisco, CA
    EASY APPLY
    $92k-$128k(Glassdoor est.)
    27 days ago 27d
    in the preparation of regulatorysubmissions and presents validations in respective SME areas to regulatory authorities during routine… ’s cGMP Manufacturing Facility in accordance with current regulatory and industry standards. This individual can execute validation…
  • 3.1
    Gilead Sciences – Foster City, CA
    $143k-$195k(Glassdoor est.)
    18 days ago 18d
    coordination of activities via the RegulatorySubmission Team. The Senior Associate in Regulatory Project Management will foster… appropriate submissions are made in accordance with applicable requirements and deadlines. The Senior Associate in Regulatory Project…
  • 3.5
    Sunovion – Fort Lee, NJ
    $187k-$240k(Glassdoor est.)
    27 days ago 27d
    estimates, detailed analysis plans, clinical study reports, regulatorysubmissions, etc.), (3) co-authoring manuscripts for publication… development experience is essential. Experience with Regulatorysubmissions, Project and proposal management and neuroscience TA…
  • 3.1
    Sanofi U.S. – Waltham, MA
    $123k-$198k(Glassdoor est.)
    11 days ago 11d
    represent the US regulatory position to senior management as needed (TPSC. DWG, IDC etc), ensure peer review of key regulatory documents… NA GBU Lead Sanofi-Genzyme (Senior Director/AVP) - Global Regulatory Affairs (GRA) The NA GBU Lead-Sanofi-Genzyme will report…
  • 2.7
    Shire – Cambridge, MA
    12 days ago 12d
    delivery of regulatorysubmissions. The SubmissionsManager is the primary point of contact for project and/or submission teams when… paper and electronic submission publishing, including the evaluation of current processes. Interpret regulatory guidelines to produce…
  • 2.7
    Shire – Cambridge, MA
    NEW
    regulatory guidelines to produce regulatorysubmission business requirements and ensure that those requirements are implemented… of regulatorysubmissions to global Health Authorities within required timeframes. The primary accountability for this role is…
  • 3.4
    Alvogen – Pine Brook, NJ
    $80k-$116k(Glassdoor est.)
    6 days ago 6d
    OF POSITION Manages team and leads Regulatory Associates and/or SeniorRegulatory Associates in regulatory activities associated… highest-quality regulatorysubmissions to the FDA within company timelines and in accordance with regulatory guidelines and…
  • 3.1
    InVision Human Services – Wexford, PA
    $45k-$64k(Glassdoor est.)
    4 days ago 4d
    clients, families, regulatory agencies, and the community. Ability to effectively present information to senior management, public… clinicians, managers, and directors. Reviews and verifies financial information such as payroll, expense and mileage submissions.…
  • 3.7
    AQR Capital Management – Greenwich, CT
    11 days ago 11d
    . Your Role Assist in the preparation and submission of all regulatory reports filed on behalf of the firm. Coordinate… financial and/or regulatory reporting, preferably with an investment manager or fund administrator, to join our Regulatory Reporting…
  • 3.5
    Cytokinetics – South San Francisco, CA
    $91k-$128k(Glassdoor est.)
    5 days ago 5d
    understanding of data analysis, data management and regulatorysubmissions Work across departments to help set priorities for… Keen understanding of the key requirements for regulatorysubmissions as stipulated in FDA and ICH guidelines for preparation…
  • 4.5
    Advanced Clinical – Cambridge, MA
    $77k-$113k(Glassdoor est.)
    NEW
    team as Contract Regulatory Affairs Project Manager in Cambridge, Massachusetts. This role will report to the Senior Vice President… Determine project timelines Ensure senior management review and approval Manageregulatory affairs project meetings Obtain…
  • 3.1
    Novavax – Gaithersburg, MD
    $173k-$216k(Glassdoor est.)
    HOT
    standards. Supports regulatory inspections as necessary, including authoring and review of regulatorysubmissions as it pertains to… personal life. The Senior Director, Quality Operations will serve as the strategic leader and operational manager to direct, oversee…
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