• Senior Director, Regulatory Operations & Systems

    Job Locations US-MA-Bedford
    Posted Date 2 weeks ago(2 weeks ago)
    Job ID
    2018-1108
    # of Openings
    1
    Category
    Regulatory
  • Responsibilities

    Provide vision and leadership for R&D electronic document management coordination & services (templates, formatting, proof-reading, publishing oversight, archiving, and user training) for Ocular Therapeutix regulatory submission components, processes and lifecycle management.  The incumbent will be responsible for evaluating and implementing an electronic document management system (EDMS) capable of managing CTD authoring, review and approval processes of regulatory submission components and source documents, oversight of eCTD publishing system, and any associated business processes. This position will also execute and maintain a system and business process for Regulatory Affair’s Information Management Systems (RIMS) for global submissions, correspondences, and commitments.

    Qualifications

     

    Responsibilities:

     

    •Oversee implementation and maintenance of electronic submission solution (EDMS), for authoring, review and approval of CTD components and source documentation.  Develop user guides and procedures for the system, including roll out and training
    •Provide expertise and support of the development of the user community for Regulatory Information Management Systems and EDMS for regulatory processes
    •Direct maintenance, training, and business administration of global RIMS and EDMS
    •Partner with Medical Affairs and Clinical Operations in the tracking, preparation, and finalization of Clinical Study Reports (CSR) and Trial Master Files (TMF) within EDMS and liaise with Clinical Quality to process and approve these documents through EDMS
    •Direct the timelines and manage the electronic publishing of regulatory submission documents to industry and company defined standards
    •Interact with regulatory agencies to obtain concurrence for electronic submission strategies.
    •Assess business trends, pending regulations and emerging technologies for potential corporate impact, develop plans and business tools accordingly
    •Develop and initiate cross functional teams to develop enhanced company Policies, Procedures, and Processes in accordance with Good Documentation Practices
    •Develop company standards and templates for regulatory submissions; ensure consistency within and across submissions
    •Analyze, author, and continuously improve Regulatory Operations work practices and guidelines
    •Oversee and maintain corporate archives and logs for all regulatory agency communications (RIMS), contribute to the continuous improvement of submission processes
    •Direct Regulatory Operations personnel that manage investigational and marketed programs submission processes
    •Contribute to overall Regulatory Affairs department cohesiveness to ensure timely submission processes
    •Direct the relationship management for the day-to-day interactions with contractors and consultants
    •Perform other duties as assigned

     

    Qualification/Experience:

     

    •Bachelor’s degree preferably in science or business-related field
    •10+ years in the pharmaceutical industry Regulatory Operations arena are required
    •10+ years of hands on experience with an eCTD Software are required
    •Advanced user skills using Microsoft Word and Adobe Acrobat desktop publishing techniques for regulatory submission documents are required
    •Extensive user experience within an enterprise Document Management System are required
    •Regulatory Submission team timeline management experience is required
    •Experience with RIMS and EDMS deployment is required
    •Experience developing Policy, Procedure, and Process from the Regulatory Operations perspective is required
    •Experience developing and delivering classroom training for Regulatory Operations processes and systems is required
    •Knowledge of the industry standards for desktop publishing or regulatory submission documents to eCTD readiness is required
    •Experience publishing Clinical Study Reports to ICH E3 standards for use in eCTDs is required
    •Experience on a cross-disciplinary Regulatory Submission Team from the Regulatory Operations services perspective is required
    •Detailed knowledge of Computer System Life Cycle Management techniques is required
    •Ability to travel approximately 5 - 10% (domestic and some international) for applicable meetings and/or educational seminars

     

     

     

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