Job Overview
We are seeking an experienced Regulatory Affairs Director to lead our global labeling strategy. As a key member of our organization, you will be responsible for developing and maintaining global labeling, including core labeling documents related to drug, device, CMC, and carton/container components.
Key Responsibilities:
* Develop and implement global labeling strategy to facilitate simultaneous global submissions.
* Implement initiatives related to global labeling strategy.
* Serve as a global labeling representative for assigned products to development teams and business partners.
* Lead the development and maintenance of core labeling, including 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 affiliates and provide support and consultation.
* Lead the development and maintenance of clinical trial Instructions for Use.
* Optimize core labeling exception process and manage core labeling exception requests.
* Support periodic labeling assessments to assess compliance of affiliate product information with core labeling.
* Resolve identified gaps and issues in labeling processes and drive continuous improvement.
* Anticipate and resolve key technical or operational issues that can impact labeling development and timelines.
Required Skills and Qualifications
* 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.
* Demonstrated ability to lead, influence, and partner cross-functionally.
* Demonstrated strong communication skills: writing, presenting, listening.
* Demonstrated effective teamwork skills; able to adapt to diverse interpersonal settings.
* Demonstrated attention to detail and organizational skills.
* Ability to learn and use new software/technology.
* Ability to manage multiple tasks simultaneously.
Benefits
This role offers a unique opportunity to develop your expertise in regulatory affairs and make a significant contribution to our organization's success.
Others
Please submit your application if you have the necessary qualifications and experience.