משרות תוצאות חיפוש מתאימות לבקשתך:

The opportunity
The RA Associate II is responsible for the supporting the development, coordination and implementation of regulatory strategies within the designated Therapeutic Area. The successful candidate will be able to prepare high quality regulatory submissions and work in a collaborative environment in the support of products in clinical development or marketed. 

Travel Requirements:   
Domestic and international travel rarely required.
How you’ll spend your day
With support from the supervisor, is responsible for maintain the regulatory compliance of marketed products, including annual reporting and safety reporting requirements  
Participates in cross functional teams including Global Regulatory Team, Clinical Development Team and Project teams   
With support from the supervisor, coordinate in planning, preparation, and execution of Health Authority meetings. Also, interact with the FDA regarding pre-clinical and clinical development issues and provide support to our ex-US Regulatory counterparts regarding preclinical and clinical support, as needed    
Oversee and ensure the preparation of INDs, NDAs, sNDAs, BLAs, and MAAs including liaising with U.S. and ex-U.S. regulatory personnel as required.  Conduct gap analyses in a timely manner.  Oversee the maintenance of INDs and NDAs, and ex-U.S. filings as required.
Represent the RA department on internal cross-functional teams for activities such as SOP development, business process improvements, etc.
Follows Teva Safety, Health, and Environmental policies and procedures