Regulatory Submission Manager
Orange County Metro Area, CA
Manage operational aspects of CE Technical File update and creation, as well as associated updates to relevant global dossiers. Under general supervision, identifies and summarizes technical information into regulatory submissions. Analyzes technical aspects of projects, and determines methods and techniques to be used and principles to be applied.
Develop documents and submission components for effective global dossiers for products (primary specialty is development of Technical Files).
Facilitate approvals by creating concise, complete and easily accessible reviewer-friendly documents.
Ensure appropriate regulatory compliance in all aspects of documents and submission components.
Ensure that sound regulatory practices are fully integrated in all technical submission documents.
Works in close collaboration with internal stakeholders and supports multiple products.
Ensures compliance with global regulatory requirements and adherence to internal policies and processes, and coordinates compliance activities at a global level.
Demonstrates ability to coordinate and work effectively with cross functional teams.
Ensures timely, clear communication on project and regulatory approval status, issues, and risks with teams, GRA line management, key internal stakeholders, and with Health Authorities.
Serve as role model and embrace Corporate Values and Behaviors
Committed to drive efficiency while maintaining quality
Demonstrates good organizational and time management skills, the ability to work on multiple projects, and adherence to timelines
Meets individual goals as defined in annual objectives
5 years directly related experience