Job Description
Lead the Development and Maintenance of Global Labeling
The position is responsible for leading the development and maintenance of global labeling, including all core labeling documents related to drug, device, CMC, and carton/container components. The successful candidate will ensure timely delivery of global labeling to affiliates to facilitate simultaneous global submissions.
The primary responsibilities include:
* Providing leadership for the development of global labeling strategy to facilitate global simultaneous submissions.
* Implementing 'Accelerate Reach and Scale' initiatives related to global labeling strategy.
* Serving as global labeling representative for assigned products to drug development teams and affiliate regulatory business partners.
Key Responsibilities
* Lead the development and maintenance of core labeling [i.e., Core Data Sheet (CDS), Core Device Labeling (CDL) that includes Core Carton, Core Quick Reference Information, and Core Instructions for Use, and CMC Core Labeling Content].
* Communicate initial and revised core labeling to global affiliates and provide support and consultation, as necessary.
* Optimize core labeling exception process and manage core labeling exception requests.
Requirements
* Bachelor's degree in a scientific or health sciences discipline (or equivalent experience).
* Industry-related experience in regulatory affairs and/or drug development experience for a minimum of 2 years.
* Demonstrated knowledge of the drug development process and regulatory/business strategies.
* Demonstrated ability to lead, influence and partner cross-functionally.