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Company Contact Info

  • Culver City, CA
  • Sara Finley

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Manager Regulatory Operations

Ascent Life Sciences • Culver City, CA

Posted 28 days ago

Job Snapshot

Experience - At least 4 year(s)
Degree - 4 Year Degree
Pharmaceutical, Biotechnology
Pharmaceutical, Biotech


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Job Description

Manager, Regulatory Operations
Los Angeles, CA
  • Coordinate daily operational activities for preparation of US and global regulatory submissions
  • Contribute to US and global Regulatory Operations strategy and resource allocation to ensure quality and timely submissions
  • Represent Regulatory Operations in cross-functional submission-planning and timeline meetings
  • Provide functional and technical guidance to more junior Regulatory Operations team members
  • Regulatory formatting, publishing, and submission building for US and global submissions
  • Ensures completion of high-quality submissions, adhering to regulatory guidelines, regional specifications, and company standards
  • Provide support for all upgrade activities for submission publishing tools and document management applications
  • Contribute to the writing, review, and implementation of standards, templates, and procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentation
  • Apply knowledge of electronic publishing requirements to ensure compliance with Health Authority submission specifications and remain current with evolving standards for global electronic submissions
  • Plan and publish regulatory submissions, ensuring timely submission of high quality, compliant and valid submissions to global health authorities within required timeframes.
  • Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues.
  • Stay current with new electronic submission and regulatory documentation practices issued from global health authorities.
  • Propose new regional and global processes for paper and electronic submission publishing, including the evaluation of current processes.
  • Provide Subject Matter Expertise for technical publishing tools and provide efficiency/enhancement proposals for the publishing tool suites.
  • Review R&D documents to ensure compliance with company submission ready standards guidelines.
  • Contribute to new and updated processes and standards.
  • Participate in validation testing of new and upgraded software
  • Responsible for the accuracy of information for submission metrics and registration information for senior management.
  • Bachelor's degree preferred or equivalent related experience and education
  • 5-7 years Regulatory Operations experience
  • Experience with Regulatory formatting and publishing is required
  • Experience with electronic submission building tool (GlobalSubmit Publish, Liquent InSight Publisher, CSC eCTDXpress, Extedo eCTDmanager, etc.) is required
  • Experience with publishing and compiling initial applications (i.e. INDs, NDAs, BLAs, MAAs) from pre-planning phase to transmission of submission is strongly preferred
  • Experience using electronic document management systems is preferred
  • Strong attention to detail
  • Ability to solve problems under pressure and is able to effectively prioritize tasks
  • Must demonstrate critical thinking, risk assessment, and sound judgment
  • Works under minimal direction and possess flexibility to work productively within an environment with evolving priorities and deadlines
  • Excellent written and verbal communications skills
  • In-depth understanding of MS Word, Word templates, and standard Office tools
  • Extensive experience using Adobe Acrobat (including advanced Toolbox features)

Questions? Please contact Sara Finley via (925) 627-4917.
Ascent Life Sciences specializes in Medical Device, Pharmaceutical, Biotech, and clinical validation search for contract staffing, contract-to-hire, direct hire search and small project consulting services for FDA-regulated industries.
Job ID: 17-04618
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