Associate Director Regulatory Operations
Paddington, United Kingdom
6d ago

Job Description

The Associate Director of Regulatory Operations UK is responsible for the oversight of the planning, preparation and submission of global Regulatory submissions.

This individual will report to the Director of Regulatory Operations and assist in the management of any UK based contractors or FTEs as well as provide direct submission support.

This individual may support the oversight of vendors supporting the regulatory submission process including creation and monitoring of KPIs and metrics.

In addition to assigned projects, the Associate Director will be responsible for ongoing evaluation of Regulatory submission processes and standards and implementing improvements to each.

In addition, the Associate Director will be responsible for providing submission expertise in the EU / International markets as well as guidance on how to operate within GRA systems and ensure EU / ROW requirements are taken into account for process improvements, submission management plans and technical requirements.

This individual will direct workflow across internal / external teams for regulatory submissions and records management and ensure compliance with evolving U.

S. and international regulations and guidelines.

Key Responsibilities :

  • Accountable and responsible for the planning, preparation and submission of global regulatory submissions.
  • Mentor individuals with various levels of experience to ensure both company goals and individual growth opportunities are met
  • Proactively make changes to team assignments as needed to support changing priorities
  • Manage vendor relationship, as needed, related to regulatory operations activities
  • Represent Regulatory Operations on assigned teams Implement processes related to submission standards, working practices, and quality controls
  • Conduct cross-functional training on submission standards, procedures, archiving standards and systems as needed
  • Be point of contact and representative for all Regulatory Operations & Compliance needs in UK Paddington location
  • Support compliance with worldwide submission regulations and guidelines by maintaining awareness and continually expanding knowledge of pertinent laws, regulations, guidance and practices.
  • Minimum Qualifications :

  • A BA / BS degree or equivalent experience
  • Extensive experience in Regulatory Operations experience
  • Extensive biotech / pharmaceutical experience or related industry experience preferred
  • Experience compiling electronic submissions and electronic publishing of submissions in eCTD format
  • Experience managing personnel (internal FTEs or vendor management)
  • Demonstrated skills managing project timelines and organizing resources
  • Strong attention to detail and the ability to manage multiple tasks
  • Extensive experience using electronic document management systems. Experience with Microsoft Sharepoint a plus
  • Preferred Qualifications :

  • Demonstrated ability to work well with cross-functional teams
  • Strong leadership and communication skills and ability to work independently
  • Strong team member and collaborative team player
  • Problem solver who can anticipate issues future needs
  • Forward thinker who can see where operational opportunities exist
  • Excellent ability to prioritize and manage multiple projects
  • Company Information

    Vertex is a global biotechnology company that invests in scientific innovation.

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