- Title: Regulatory Affairs Associate
- Code: RCI-11213442
- Location: Wilson North Carolina (NC) 27893
- Posted Date: 09/15/2020
- Duration: 11 Months
Talk to our Recruiter
- Name:Vishal Trivedi
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 435
- Contributes to the preparation and submission of regulatory filing documents.
- Monitors and tracks information and requirement changes.
- Provides assistance to members of the RA team in the compilation of ANDAs, Amendments, Supplements, Annual Reports, etc. for FDA submissions.
- Maintains compliance with regulatory requirements for generic drugs for the US market.
- Reviews ANDA labeling documents
- Maintains Regulatory Databases
- Receives general supervision and detailed instruction on new projects
- This position has no supervisory responsibility.
Key Performance Indicators:
- Knowledge: Limited use and/or application of technical principles, theories, and concepts.
- Problem Solving: Develop solutions to routine technical problems of limited scope.
- Bachelor’s degree in a scientific related field