Global Regulatory Affairs Director Opportunity
We are seeking a highly skilled and experienced Global Regulatory Affairs Director to lead our regulatory team.
The successful candidate will be responsible for developing and maintaining global labeling, including core labeling documents related to drug, device, CMC, and carton/container components.
The Global Regulatory Affairs Director will provide leadership for the development of global labeling strategy to facilitate global simultaneous submissions, implement "Accelerate Reach and Scale" initiatives, and serve as a global labeling representative for assigned products.
Key Responsibilities:
* Develop and maintain global labeling strategy
* Lead the development and maintenance of core labeling documents
* Serve as a global labeling representative for assigned products
* Implement "Accelerate Reach and Scale" initiatives
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