The primary responsibility of this position is to prepare and review documentation for regulatory submissions including ANDAs, Amendments, Annuals Reports Supplements, labeling review and change control. The individual will manage and maintain FDA drug applications with supervision. The individual is responsible for ensuring submissions meet FDA requirements and internal timelines.
Specialized Skills and Knowledge:
1. Ability to communicate effectively on Regulatory strategies and opinion
3. Ability to work on multiple projects at a time
4. Efficient in word, adobe, and excel
Work is primarily sedentary in nature; routine bending, walking, lifting and reaching are required.
Avet is proud to be an Equal Opportunity Employer.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs
|Job Category||Regulatory Affairs|