Associate Director - Global Core Labeling (Regulatory Affairs)
We are seeking a talented professional to lead the development and maintenance of global labeling for a leading healthcare company.
The successful candidate will be responsible for ensuring timely delivery of global labeling to our clients' affiliates, facilitating simultaneous global submissions, and communicating core labeling changes throughout the product lifecycle.
Key Responsibilities:
* Develop and implement a global labeling strategy to support accelerated reach and scale initiatives.
* Lead the preparation and approval of core labeling by cross-functional teams and stakeholders.
* Communicate core labeling updates to global affiliates and provide support and consultation as needed.
Core Labeling Development and Maintenance
* Develop and maintain core labeling documents, including Core Data Sheet, Core Device Labeling, and Clinical Trial Instructions for Use.
* Facilitate approval of core labeling by governance forums and other stakeholders.
* Serve as subject matter expert for core labeling and drive continuous improvement in labeling processes.
Labeling Process Excellence
* Optimize core labeling exception process and manage exception requests.
* Support periodic labeling assessments to ensure compliance with core labeling.
* Develop and present metrics to track and improve labeling exception process performance.
Requirements:
* Bachelor's degree in a scientific or health sciences discipline.
* Minimum 2 years of experience in regulatory affairs and/or drug development.
* Demonstrated knowledge of the drug development process and regulatory strategies.
* Strong leadership, communication, and teamwork skills.
* Ability to manage multiple tasks and prioritize effectively.