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