Job Type
Date Posted
Salary Range
Distance

Regulatory Submissions Manager Jobs

2,890 Jobs

  • 3.1
    Gilead Sciences – Foster City, CA
    $90k-$123k(Glassdoor est.)
    5 days ago 5d
    coordination of activities via the RegulatorySubmission Team. The Associate Manager in Regulatory Project Management will foster… lead of cross-regional submissions. Influence within RPM team The Associate Manager in Regulatory Project Management may…
  • 2.7
    Shire – Cambridge, MA
    $115k-$156k(Glassdoor est.)
    21 days ago 21d
    cross-functional submission teams and the GRT. Work with submission management on the development of regulatorysubmissions. Support… high quality regulatorysubmissions for assigned products, including both pre-approval and postmarketing submissions. Scope includes…
  • 3.6
    Bausch & Lomb – Tampa, FL
    $99k-$144k(Glassdoor est.)
    13 days ago 13d
    Coordinate with Regulatory Operations to ensure timely and accurate submissions to Regulatory Authorities. Manage interactions with… manufacturing changes for regulatory impact, coordinating development of regulatory strategies for regulatorysubmissions in support of the…
  • 3.4
    MedImmune, LLC – Gaithersburg, MD
    5 days ago 5d
    representative to provide submission related expertise Lead the process of critical review of regulatory documents and incorporating… , and help fight and cure disease. As a BioOperations SubmissionManager in Gaithersburg MD, you’ll play a pivotal role in channeling…
  • 2.4
    Medpace – Cincinnati, OH
    12 days ago 12d
    are currently seeking a full-time, office-based RegulatorySubmissionsManager to join our Clinical Operations team. This position… Efficiently manage and successfully execute all aspects of global start-up; Perform quality checks on submission documents and…
  • 3.6
    Bristol-Myers Squibb – United States
    NEW
    regard to regulatory and submission requirements, submission strategies, dossier content, and format. SubmissionManagers are also… to these guidelines. The SubmissionManager demonstrates a strong working knowledge of global regulatory practices and requirements…
  • 5.0
    GLAUKOS (CA) – San Clemente, CA
    $64k-$128k(Glassdoor est.)
    Today 1hr
    · Interact with regulatory agencies (FDA, EMA) regarding regulatorysubmissions and agency queries. Manage and Prioritize Assigned… The Senior Manager/Manager will also be responsible for the on-time filing of high-quality regulatorysubmissions for new products…
  • 3.6
    Bristol-Myers Squibb – United States
    7 days ago 7d
    regard to regulatory and submission requirements, submission strategies, dossier content, and format. SubmissionManagers are also… to these guidelines. The SubmissionManager demonstrates a strong working knowledge of global regulatory practices and requirements…
  • 4.0
    Genentech – South San Francisco, CA
    NEW
    formatting tasks on regulatorysubmissions, including marketing applications, under the direction of a SubmissionManager. You… production of quality regulatory filings across Roche. In this position, you will work with SubmissionManagers and Information Specialists…
  • 3.6
    Moderna Therapeutics – Cambridge, MA
    16 days ago 16d
    materials for regulatory compliance. Partners with internal teams and Moderna partners to develop content and managesubmissions to regulatory… Develops content, format and accountability for regulatorysubmissions and related supplements and amendments. Advises project…
  • 4.4
    Agios Pharmaceuticals – Cambridge, MA
    $117k-$164k(Glassdoor est.)
    26 days ago 26d
    write and review CMC sections across all pertinent regulatorysubmissions (i.e. clinical trial and marketing applications, formal… formal meetings, life-cycle management submissions) Develop and execute CMC regulatory strategy for long-term planning including…
  • 3.1
    Gilead Sciences – Foster City, CA
    $193k-$313k(Glassdoor est.)
    NEW
    ), and submission production and validation tools and strategies, to assist members of Regulatory Affairs in submission preparation… familiarity with pharmaceutical development and global Regulatorysubmission processes is required. Requires an in-depth understanding…
  • 4.2
    Indiana University – Indianapolis, IN
    NEW
    responsibilities will be directly involved with the submission and maintenance of all regulatory documentation locally. All of these studies… Emergency Medicine is seeking candidates for the SIREN RegulatoryManager position. This position will act as liaison between research…
  • 4.8
    fabergent – Green Oaks, IL
    $46k-$70k(Glassdoor est.)
    NEW
    labeling needed for regulatorysubmissions is available in the global labeling repository (Pending Submissions) Provides labeling… withdrawals, submissions and approvals in the global labeling repository (GLS) Partners with Global Submissions Operations to…
  • 4.3
    Institute for Healthcare Improvement – Cambridge, MA
    EASY APPLY
    $60k-$105k(Glassdoor est.)
    4 days ago 4d
    organizational, program, and budget information required for proposal submission, and ensure that that inputs are compliant and competitive… changing clients, funders, partners, competitive landscape, regulatory environment) Support the day-to-day operations and management…
  • 3.4
    NantWorks – Culver City, CA
    $77k-$148k(Glassdoor est.)
    11 days ago 11d
    requirements and authors CMC sections of submissions to regulatory authorities, summarizes regulatory intelligence, and assists with other… resulting in high quality submissions. Evaluates proposed changes for regulatory impact and submission requirements with minimal…
  • 4.5
    Advanced Clinical – Cambridge, MA
    $77k-$113k(Glassdoor est.)
    4 days ago 4d
    successful track record with regulatorysubmissions (INDs, CTAs NDAs, CTDs/eCTDs) required Knowledge of regulatory processes, guidelines… RESPONSIBILITIES Develop detailed project plans for regulatorysubmissions Work with team(s) to draft plans, define content,…
  • 3.1
    Sanofi U.S. – Bridgewater, NJ
    $170k-$235k(Glassdoor est.)
    5 days ago 5d
    mitigations, global submission strategies, and reimbursement strategies. The GRTL will work with the global regulatory team to ensure… assessed. •Assess the accuracy and appropriateness of submissions to regulatory authorities to support successful clinical trial applications…
  • 3.6
    Bausch & Lomb – Bridgewater, NJ
    $114k-$163k(Glassdoor est.)
    HOT
    specific pharmaceutical Regulatory Affairs personnel for international submissions and registrations Manage interactions with other… and regulatory responses Demonstrated experience with health authority submissions, i.e, authored, reviewed and managed an original…
  • 4.0
    State of Virginia – Charlottesville, VA
    Today 2hr
    Good Clinical Practice (GCP) compliance and assists the RegulatoryManager. The position requires strong written communication skills… completes and maintains regulatory documents for clinical studies/trials to ensure protocol, regulatory and Standard Operating…
  • 4.2
    Smith Hanley Associates – Bridgewater, NJ
    NEW
    mitigations, global submission strategies, and reimbursement strategies. The GRTL will work with the global regulatory team to ensure… assessed. 8.Assess the accuracy and appropriateness of submissions to regulatory authorities to support successful clinical trial applications…
  • 3.1
    Next Level Health Partners, LLC – Chicago, IL
    EASY APPLY
    $48k-$81k(Glassdoor est.)
    HOT
    and preparation of required compliance reports, submissions, etc. to regulatory entities as requested. Support the review process…
  • 3.5
    Vertex Pharmaceuticals – Boston, MA
    $76k-$106k(Glassdoor est.)
    7 days ago 7d
    filing of regulatory CMC submissions and manage the interactions with Health Authorities for CMC topics. Provide regulatory support… review of CMC sections of regulatorysubmissions, as well as the interactions and responses with regulatory agencies Develop global…
  • 3.4
    Biogen – Cambridge, MA
    12 days ago 12d
    global regulatorysubmissions related to adverse event reporting, expedited or periodic as well as submissions to ethics committees… periodic submissions to global regulatory authorities for clinical trial and marketed products to ensure regulatory compliance…
  • 3.1
    LSI Solutions – Victor, NY
    $91k-$128k(Glassdoor est.)
    26 days ago 26d
    Leadership. Support the preparation of global regulatory documentation and managesubmission activities to meet business and agency… international and domestic regulatorysubmissions. Plan and implement domestic and international regulatory compliance strategies…
  • 3.9
    The Fountain Group – Cambridge, MA
    Today 10hr
    for product-specific global regulatory team meetings (GRTs) and cross-functional major submission team meetings to oversee, plan… plan and deliver GRT goals and regulatorysubmissions. For assigned programs, prepare meeting agendas, meeting minutes, and together…
  • 4.0
    Stryker – Fremont, CA
    $90k-$123k(Glassdoor est.)
    NEW
    Project Manager, Regulatory Affairs provides leadership, organization and coordination of the Neurovascular global regulatory strategies… and post-market basis. Additionally, the Project Manager, RegulatoryManager will work with project teams and management to execute…
  • 3.6
    Bausch & Lomb – Tampa, FL
    $101k-$140k(Glassdoor est.)
    HOT
    Coordinate with Regulatory Operations to ensure timely and accurate submissions to Regulatory Authorities. Manage interactions with… manufacturing changes for regulatory impact, coordinating development of regulatory strategies for regulatorysubmissions in support of the…
  • 3.7
    ImmunoGen – Waltham, MA
    $59k-$90k(Glassdoor est.)
    NEW
    support drug development processes and global project submissions through to approval. Responsibilities Responsible for all… C-DASH and SDTM preferred Experience with NDA, BLA, MAA submissions highly desirable Familiar with advanced concepts of clinical…
  • 4.5
    Advanced Clinical – Fort Lee, NJ
    $82k-$115k(Glassdoor est.)
    NEW
    sections of regulatory documents like Investigators Brochures, briefing books, safety updates, IND/NDA submission documents, responses… being conversant in regulatory guidelines and clinical terminology. Organized. Youre an efficient time-manager and can handle the…
Page 2 of 97
Work in HR or Recruiting?