Associate Director - Global Core Labeling (Regulatory Affairs)
We are seeking a seasoned professional to join our team as an Associate Director, Global Regulatory Affairs (GRA) Global Core Labeling. The successful candidate will be responsible for leading the development and maintenance of global labeling, including all core labeling documents related to drug, device, CMC, and carton/container components.
Key Responsibilities:
* Provide leadership for the development of global labeling strategy to facilitate simultaneous global submissions.
* Implement Accelerate Reach and Scale initiatives related to global labeling strategy.
* Serve as global labeling representative for assigned products to drug development teams and affiliate regulatory business partners.
Core Labeling Development and Maintenance:
* 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].
* Lead the preparation activities and facilitate approval of core labeling by the Global Product Labeling Committee (GPLC) and Global Labeling Council (GLC).
* Communicate initial and revised core labeling to global affiliates and provide support and consultation, as necessary.
Labeling Process Excellence:
* Optimize core labeling exception process.
* Manage core labeling exception requests and facilitate approval from leadership.
* Support periodic labeling assessments to assess compliance of affiliate product information with core labeling.
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 assess and manage risk in a highly regulatory environment.