Global Labeling Expert
We are seeking a seasoned professional to lead our global labeling efforts. As a Global Labeling Expert, you will play a key role in developing and maintaining our company's labeling strategy.
Key Responsibilities
* Develop and implement global labeling strategies to facilitate simultaneous submissions.
* Lead the development and maintenance of core labeling documents related to drug, device, CMC, and carton/container components.
* Collaborate with cross-functional teams to ensure timely delivery of global labeling to affiliates.
* Communicate labeling updates and changes throughout the product lifecycle.
* Optimize labeling exception processes and manage requests for approval.
Qualifications
* Bachelor's degree in a scientific or health sciences discipline (or equivalent experience).
* Industry-related experience in regulatory affairs and/or drug development 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 regulated environment.
* Demonstrated leadership, communication, and teamwork skills.
* Demonstrated attention to detail and organizational skills.
This is an exciting opportunity for a motivated professional to join our team and contribute to the success of our global labeling initiatives.