Regulatory Submissions Manager Jobs in Cambridge, MA | Glassdoor
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Regulatory Submissions Manager Jobs in Cambridge, MA

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  • 3.1
    Shire Pharmaceuticals LLC – Cambridge, MA
    NEW
    regulatory guidelines to produce regulatorysubmission business requirements and ensure that those requirements are implemented… and eCTD submissions and using related tools. Strong understanding of global regulatory requirements and submission processes…
  • 4.5
    Advanced Clinical – Cambridge, MA
    Today 5hr
    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…
  • 5.0
    BioPoint – Cambridge, MA
    Est. Salary $49k-$74k
    NEW
    the Global Regulatory Lead, as manager of cross-functional submission team, will plan and manageregulatorysubmissions and author… Global RegulatorySubmissions Associate for a position in Cambridge, MA. OBJECTIVES: The Global SubmissionManager (GSM)…
  • 4.4
    Agios Pharmaceuticals – Cambridge, MA
    Est. Salary $92k-$156k
    21 days ago 21d
    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…
  • 3.8
    Ironwood Pharmaceuticals – Cambridge, MA
    25 days ago 25d
    Working with Regulatory Affairs and Regulatory Operations, the SubmissionManager establishes and maintains submission plans and… The RegulatorySubmissionManager has overall responsibility for managing Ironwood’s submission projects involving multiple…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    NEW
    Publication and submission of electronic submissions (and paper submissions, when required) to regulatory agencies to support… electronic submissions. Provides support to Regulatory Affairs and other project stakeholders in the creation of submissions documents…
  • 4.3
    bluebird bio – Cambridge, MA
    Est. Salary $81k-$138k
    23 days ago 23d
    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…
  • 3.1
    Shire – Cambridge, MA
    Est. Salary $78k-$134k
    NEW
    timeliness of regulatorysubmissions for their assigned business unit(s). This role is responsible for setting the vision for assigned… overall operational effectiveness for regulatorysubmissions. The GRO Portfolio Lead also plays a key role in user requirements gathering…
  • 4.5
    Advanced Clinical – Cambridge, MA
    Est. Salary $152k-$204k
    Today 5hr
    review of regulatorysubmissions and interfacing with authorities, coordinating all aspects of regulatorysubmissions and proactively… Director of Regulatory Affairs will work with a cross-functional team to implement regulatory strategy, data and submission packages…
  • 4.3
    bluebird bio – Cambridge, MA
    Est. Salary $80k-$103k
    22 days ago 22d
    not be limited to: RIMS, Submissions Authoring, Publishing and Validation, and Electronic Submissions Gateway. We are interested… with the Regulatory Ops Business Owner to provide support in managing both ongoing and future projects within the Regulatory Affairs…
  • 3.4
    Biogen – Cambridge, MA
    NEW
    oversight of 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
    Shire Pharmaceuticals LLC – Cambridge, MA
    7 days ago 7d
    Ad Promo regulatory compliance submissions, including compliance with agreed upon metrics and ensuring timely submission of high… publishing (paper, NeES, eCTD), review and dispatch of regulatory compliance submissions to global Health Authorities within required timeframes…
  • 3.1
    Synectics – Cambridge, MA
    NEW
    the Global Regulatory Lead, as manager of cross-functional submission team, will plan and manageregulatorysubmissions and author… compliant submissions, prepared for global regulatory agencies, in accordance with the worldwide regulatorysubmission plan. Sets…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    Est. Salary $120k-$192k
    28 days ago 28d
    review, and submission of regulatory documents maintaining compliance with regulatory requirements. Prepare regulatory agency meeting… Responsibilities Develop regulatory strategy and submission plans for quality and timely filings. Provide regulatory guidance regarding…
  • 4.0
    Tesaro – Waltham, MA
    Est. Salary $97k-$140k
    20 days ago 20d
    preparation and submission of regulatory documentation as well as the design of clinical trials • Create regulatorysubmission timelines… teams • Manage internal team and external consultants/vendors to regulatory timelines • Provide input into regulatory development…
  • 3.1
    Shire Pharmaceuticals LLC – Lexington, MA
    23 days ago 23d
    Undertake the submission build activities for both paper and electronic regulatorysubmissions, ensuring submissions are built with… pertaining to regulatory filings/submissions on request On occasion will QC selected CMC sections of regulatory filings 10%…
  • 4.1
    Integrated Resources – Cambridge, MA
    NEW
    the Global Regulatory Lead, as manager of cross-functional submission team, will plan and manageregulatorysubmissions and author… compliant submissions, prepared for global regulatory agencies, in accordance with the worldwide regulatorysubmission plan. Sets…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    Est. Salary $120k-$192k
    17 days ago 17d
    highly-visible role that is responsible for CMC regulatory activities, strategies and submissions supporting the development and commercialization… Serve as CMC regulatory lead at internal meetings as well as at meetings with business partners and regulatory agencies for all…
  • 3.9
    Planet Pharma – Cambridge, MA
    4 days ago 4d
    the Global Regulatory Lead, as manager of cross-functional submission team, will plan and manageregulatorysubmissions and author… Category: Regulatory Affairs Industry: Pharmaceutical OBJECTIVES: The Global SubmissionManager (GSM) is accountable…
  • 3.1
    Shire – Cambridge, MA
    13 days ago 13d
    the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans… and backup strategy for label negotiations. Manages the preparation of submission-ready labeling components; consults with affiliates…
  • 3.8
    Ironwood Pharmaceuticals – Cambridge, MA
    Est. Salary $136k-$197k
    1 days ago 20hr
    support regulatorysubmission activities including eCTD production, document publishing, and document management. In addition… Responsibilities: Represent Regulatory Operations by participating on assigned teams to support submission scheduling and ensure coordination…
  • 4.5
    Green Key Resources – Cambridge, MA
    15 days ago 15d
    support to ensure the Regulatory Lead and cross functional program team develop andexecute global regulatory strategies Utilize… program teams, sub-teams, and senior stakeholders Assist regulatory lead in problem solving and generate options to enable effective…
  • 4.4
    Agios Pharmaceuticals – Cambridge, MA
    Est. Salary $92k-$134k
    25 days ago 25d
    reimbursement barriers Coordination and development of submissions to guideline and compendia bodies (e.g NCCN) Oversee development… commercialization process and knowledge of the legal and regulatory guidelines • Able to integrate and apply feedback in a professional…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    Est. Salary $52k-$114k
    NEW
    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…
  • 3.5
    EMD Serono – Billerica, MA
    Est. Salary $120k-$167k
    7 days ago 7d
    in preparation and execution of global regulatory strategies and to manage the submission and approval of applications for clinical… written and spoken English Ability to manage and upon occasion lead regulatorysubmission process within the avelumab program…
  • 3.1
    Shire – Lexington, MA
    NEW
    Responsibilities: 70% Manage preparation, writing, review of nonclinical components of regulatorysubmissions and all technical documents… quality, submission-ready submission components that are consistent with relevant regulatory guidelines for global submissions.…
  • 3.4
    Takeda Pharmaceuticals – Cambridge, MA
    Est. Salary $104k-$185k
    6 days ago 6d
    POSITION ACCOUNTABILITIES: Plans, executes and managesregulatorysubmissions for assigned compounds in various phases of clinical… CMC content (data and documentation) requirements for regulatorysubmissions and reviews this content for conformance with established…
  • 3.1
    Sanofi U.S. – Cambridge, MA
    Est. Salary $97k-$142k
    9 days ago 9d
    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…
  • 4.3
    bluebird bio – Cambridge, MA
    NEW
    Prepare submissions plans and manage timelines for regulatorysubmissions Prepare and review sections of regulatory submissions… requirements including SOPs Manageregulatory documentation and submission logs Assist team during regulatory agencies inspections…
  • 4.0
    Tesaro – Waltham, MA
    Est. Salary $111k-$151k
    4 days ago 4d
    • 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…
  • 3.4
    Takeda Pharmaceuticals – Cambridge, MA
    Est. Salary $123k-$177k
    6 days ago 6d
    facilitation and preparation of Emerging Markets regulatory documents and various submissions, as well as any compliance matters; Applies… POSITION ACCOUNTABILITIES: Executes the regulatorysubmissions to support product development and approval efforts…
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