Job Title: Global Regulatory Affairs Leader
The role 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.
Key Responsibilities:
* Develop a global labeling strategy that facilitates simultaneous submissions worldwide.
* Implement initiatives to accelerate regulatory processes and improve labeling efficiency.
* Represent the company in global regulatory matters and collaborate with cross-functional teams.
* Lead the creation and maintenance of core labeling content, including Core Data Sheet (CDS), Core Device Labeling (CDL), and CMC Core Labeling Content.
* Communicate initial and revised core labeling to global affiliates and provide consultation as needed.
* Optimize the core labeling exception process and manage exception requests.
* Develop and present metrics to stakeholders to monitor and improve the labeling exception process.
Requirements:
* Bachelor's degree in a scientific or health sciences discipline or equivalent experience.
* A minimum of 2 years of industry-related experience in regulatory affairs and/or drug development.
* Demonstrated knowledge of the drug development process and regulatory/business strategies.
* Ability to assess and manage risk in a highly regulated environment.
* Leadership and collaboration skills to drive cross-functional partnerships.