The Associate Director of Regulatory Operations is responsible for the oversight of the preparation and submission of global Regulatory submissions. This individual will report to the Director of Regulatory Operations and assist in the management of any 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.
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.
* Accountable and responsible for the preparation and submission of global regulatory submissions.
* Manage team 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
* Support compliance with worldwide submission regulations and guidelines by maintaining awareness and continually expanding knowledge of pertinent laws, regulations, guidance and practices.
* A BA/BS degree or equivalent experience
* At least 8 years of Regulatory Operations experience; 8-10 years of total biotech/pharmaceutical 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
* 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
Associated topics: administrative coordinator, beverage, chief operations officer, front desk, front office, food, operational assistant, operational support, operations director, records management