Regulatory Submissions Manager Jobs | Glassdoor
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Regulatory Submissions Manager Jobs

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  • 3.2
    Next Level Health Partners, LLC – Chicago, IL
    EASY APPLY
    Est. Salary $48k-$80k
    NEW
    and preparation of required compliance reports, submissions, etc. to regulatory entities as requested. Support the review process…
  • 3.3
    Gilead Sciences – Foster City, CA
    Est. Salary $91k-$125k
    6 days ago 6d
    Responsible for preparing regulatorysubmissions which require interactions with departments outside of Regulatory Affairs for investigational… programs/projects. Responsible with manager for development and acquisition of required regulatory skills and knowledge. May initiate…
  • 3.7
    Regeneron – Tarrytown, NY
    Est. Salary $103k-$192k
    9 days ago 9d
    Pharmaceutical experience is a plus Regulatorysubmission experience Understanding of global regulatory requirements for device and… product regulatory activities, including device development activities, protocols reviews, HA correspondence and submission.…
  • 4.7
    BioPhase Solutions Inc. – San Diego, CA
    Est. Salary $46k-$105k
    Today 10hr
    Manager of Regulatory Operations is responsible for managing all aspects of document development for electronic submission to global… Assemble and e-publish documents to be included in regulatorysubmissions to FDA and other health authorities. Set priorities…
  • 3.6
    Medtronic Inc. – Northridge, CA
    Est. Salary $101k-$131k
    7 days ago 7d
    Position: Principal Regulatory Affairs Specialist -Premarket Approval (PMA) submissions Location: Northridge, CA Bringyour… Approval (PMA) submission expertise and join our Diabetes Group RegulatoryAffairs organization to develop regulatory strategy, prepare…
  • Randstad Life Sciences – South Plainfield, NJ
    NEW
    required for US and global regulatorysubmissions; confirms the accuracy and quality of submission content, obtains required approvals… Maintains and tracks regulatorysubmission documentation (hard copy or electronic), including regulatory authority correspondence…
  • 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…
  • 2.6
    Organogenesis – La Jolla, CA
    Est. Salary $103k-$157k
    21 days ago 21d
    developing regulatory strategies, planning and preparing regulatorysubmissions required. Experience with regulatory product lifecycle… preparation of submissions and reports to FDA and other regulatory agencies, as well as interfacing with these regulatory agencies.…
  • 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…
  • 5.0
    Cameron Craig Group – San Francisco, CA
    Est. Salary $163k-$214k
    Today 11hr
    responsible for the regulatory CMC strategy of submissions for all products as well as managing interactions with regulatory authorities… the business benefit balanced with regulatory compliance. Lead and drive all CMC submission activities (planning, authoring, reviewing…
  • 3.3
    Gilead Sciences – Foster City, CA
    Est. Salary $97k-$143k
    13 days ago 13d
    of regulatory affairs CMC strategy for investigational and commercial drugs. Communicate submission status and regulatory affairs… .gilead.com/ Responsible for the preparation of regulatorysubmissions, including those that may be considered moderately complex…
  • 4.0
    Adare Pharmaceuticals – Dayton, OH
    Est. Salary $73k-$130k
    NEW
    appropriate regulatory management of labelling changes. Serves as company expert for electronic regulatorysubmission requirements… electronic product registration submissions, pharmaceutical product labelling materials and regulatory documentation to support early…
  • 4.0
    Roche – Tucson, AZ
    Est. Salary $61k-$95k
    Today 15min
    preferred. Regulatory Affairs Certification preferred. Experience: Minimum 5 years experience in regulatory, development… industries. Regulatory Affairs experience is preferred. IVD device experience is preferred. Experience with regulatory submissions…
  • 3.4
    Randstad US – South Plainfield, NJ
    NEW
    required for US and global regulatorysubmissions; confirms the accuracy and quality of submission content, obtains required approvals… Maintains and tracks regulatorysubmission documentation (hard copy or electronic), including regulatory authority correspondence…
  • 3.6
    Novartis – Fort Worth, TX
    8 days ago 8d
    handling global regulatorysubmissions. Extensive knowledge of the organization of Health authority submissions Knowledgeable of… Format •Delegates submission activities to GSP (Global Submission Publishers) and GSM (Global SubmissionManagers) located in India…
  • 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…
  • 3.4
    PrimePay, LLC. – West Chester, PA
    Est. Salary $51k-$86k
    21 days ago 21d
    role of Regulatory Compliance Manager in our West Chester, PA office. Under the direction of the Vice President of Regulatory Compliance… Compliance, the Regulatory Compliance Manager assists in monitoring the compliance of the PrimePay Benefit Services solutions. This…
  • 2.6
    Eisai Inc. – Woodcliff Lake, NJ
    Est. Salary $108k-$149k
    17 days ago 17d
    Committee (PMRC). The Senior Manager, Commercial Regulatory Affairs also leads the Commercial Regulatory Affairs function responsible… match your qualifications and interests. The Sr. Manager, Commercial Regulatory Affairs provides strategic input into the review…
  • 4.5
    Advanced Clinical – Abbott Park, IL
    Est. Salary $45k-$67k
    1 days ago 1d
    with multiple departments, as appropriate, involved in regulatorysubmissions Receiving documents from various sources and review… as needed Reviewing regulatory documents to assure FDA requirements are met and are ready for submission Responsible to handle…
  • 3.7
    Pfizer – Groton, CT
    Est. Salary $74k-$103k
    NEW
    corporate policies governing documents for regulatorysubmission. Provide project teams with expertise and strategic guidance on analysis… guidance. Knows and interprets regulatory guidance in context of specific products and submission documents. Is able to synthesize…
  • 3.7
    Pfizer – Groton, CT
    Est. Salary $130k-$182k
    NEW
    CD&O deliverables for a submission. Including inspection readiness, submission and regulatory defense. The CPM is an expert on… forecasting and managing the CD&O submission budget Leads the submission sub-teams (blocks 2 & 5); manages, facilitates and documents…
  • 4.1
    Tax Defense Network – Jacksonville, FL
    Est. Salary $42k-$73k
    10 days ago 10d
    keyword lists and ad copy, prepare regulatorysubmissions and oversee their approval process Manage bids and budgets, test and optimize… The SEO Manager will work to develop, manage, optimize and report on SEO, paid search, paid social and related digital campaigns…
  • 3.3
    Gilead Sciences – Foster City, CA
    Est. Salary $103k-$152k
    15 days ago 15d
    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…
  • 3.9
    Stryker – Allendale, NJ
    Est. Salary $79k-$120k
    Today 11hr
    and EU regulatory requirements are incorporated as part of the development process Author submissions and other regulatory documents… Authorities and other regulatory agencies on submissions, approvals or other issues Establish and maintain regulatory information systems…
  • 3.3
    Gilead Sciences – Foster City, CA
    24 days ago 24d
    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…
  • 3.7
    Hologic – San Diego, CA
    Est. Salary $67k-$104k
    NEW
    graphics, and reports are accurate and complete for regulatorysubmissions & scientific publications. Recommends and initiates… Hologic is seeking a Clinical Data Manager responsible for performing data management activities including data cleaning, query…
  • 3.7
    Pfizer – Collegeville, PA
    Est. Salary $96k-$138k
    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…
  • 4.0
    Jumpstart – Oberlin, OH
    EASY APPLY
    Est. Salary $38k-$61k
    1 days ago 15hr
    engineering) for inclusion in regulatorysubmissions. • Interact with FDA reviewers and other regulatory agency personnel in meetings… Novo and 510(k)) and postmarket submissions to FDA. Interact with FDA reviewers and other regulatory agency personnel. Duties and…
  • 3.7
    Regeneron – Tarrytown, NY
    Est. Salary $103k-$192k
    16 days ago 16d
    global regulatory requirements and regulations for devices and combination products is a must Regulatorysubmission experience… life cycle management Support combination products regulatorysubmissions, reviews, approvals and HA interactions as related to…
  • 2.5
    Revlon – Edison, NJ
    NEW
    or analyses, evaluations, preparations and submissions of documentation for regulatory registration and/or governmental approval… market, as requested. Meets on a weekly basis with the Manager, Regulatory Affairs to provide progress report and advise of any…
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