Job Details

  • Title: Vault RT Support Specialist
  • Code: RCI-02603
  • Location: Bridgewater New Jersey (NJ) 08807
  • Posted Date: 09/21/2020
  • Duration: 24 Months
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  Job Description

As Client is transforming into digital technology for data management to bring our regulatory compliance into a higher standard of data use and protection, Global Regulatory Affairs CMC & Devices is being integrated in Veeva Vault, a part of regulatory management system. Small Molecule Development (SMD) group as a key stakeholder within GRA CMC&D organization contributes to pipeline success by ensuring regulatory approval for NMEs and NCEs to bring innovative medicines to patients.

Vault allows accurate Registration Tracking (RT) for all regulatory events including initial submission, amendments, Health Authority query response, approval and life cycle management. With ever increasing demands for regulatory submission of development compounds, we have created a new position within GRA CMC&D function to support Vault RT for SMD group. As our Vault RT Support Expert, you will represent SMD Regulatory CMC managers to ensure the proper entry of CMC registration information, maintenance of up-to-date submission records, management of life cycle CMC registration in Vault in alignment with process. Be responsible for managing registration tracking for all CMC submission and Health Authority correspondences related to CMC in Veeva Vault. Interaction with Regulatory CMC managers and GRA Operations in support of SMD business activities.

Responsibilities:

  • Responsible to manage Vault Registration Tracking for CMC regulatory submission for GRA CMC&D Small Molecule Development (SMD) group
  • Represent SMD RA CMC managers to ensure the proper entry of registration information for CMC submission in Vault in alignment with process
  • Manage registration of CMC sections for investigational application and marketing application, including updates to registered data and report on approval status
  • Plan, manage, and track the status of regulatory CMC submissions and related administrative activities. This includes information and data entry and uploading submission documentation related to initial clinical trial application (IMPD/IND) and subsequent CMC amendments, and initial marketing authorization application (NDA/MAA)
  • Maintain up-to-date CMC submission tracking for IMPD/IND and amendments and NDA/MAA and Health Authority correspondences in Veeva Vault
  • Maintain and classify CMC correspondence with Health Authorities, including contact records, meeting requests and packages. Create submission and interaction records and report on progress against outstanding commitments and deliverables
  • Manage CMC submission tracking in Veeva Vault including creation, initiation of workflow, closing and archiving
  • Responsible as a superuser to provide timely support for SMD RA CMC managers to ensure Vault Registration Tracking and administrative activities for CMC submission
  • Identify potential issues and project timeline conflicts. Drive to ensure timely and appropriate resolution of the issues. Consult with SMD RA CMC managers for troubleshooting issues
  • Recommend continuous improvement and simplification of Vault RT for CMC submission for development compounds
  • Provide input to the creation of user-friendly guide for CMC registration tracking for development compounds

Challenges of the job:

  • Experience with the dynamic regulatory environment and systems
  • Expertise in regulatory operations
  • Understanding in regulatory CMC strategy and CMC submission planning
  • Understanding of CMC sections for clinical trial applications and marketing applications
  • Managing expectations on deliverables to meet tight timelines. Handling timeline pressure
  • Cultivating business relationships with GRA, Reg Ops, RA CMC, CDDC, GRA regions and local affiliates
  • Helping SMD RA CMC managers to acquaint Veeva Vault Registration Tracking process and system
  • Ability to quickly analyze issues to troubleshoot for resolution for business continuity
Required:
  • Bachelor's degree in science, library or information management or equivalent experience
  • Minimum five years of experience in the pharmaceutical industry with a minimum of three years in Regulatory Operations, Registration Tracking, or CMC regulatory documentation management
  • Knowledge of Regulatory Operations domain, Regulatory CMC documentation management
  • Expertise experience working with Veeva Vault for registration tracking and regulatory CMC documentation management are required. Experience with other systems are desired
  • A good understanding of the different domains within Regulatory Affairs including dossier creation, document management, publishing, registration tracking and submission reporting
  • Working knowledge of regulatory CMC submission requirements. CMC dossiers for clinical trial applications and marketing applications in terms of CTD content and structure
  • Experience with Veeva Vault or similar systems (such as SHARE etc.) and a deep understanding in Registration Tracking process in Vault
  • Good understanding of Regulatory CMC dossiers for clinical trial applications and marketing applications in terms of CTD content and structure
  • Knowledge of CMC initial submission and amendment
  • Expertise in e-CTD submission requirements