New Regulatory Affairs Associate I Job in Wilson, NC!
Position Title: Regulatory Affairs Associate I

Position Number: 346377

Location: Wilson, NC 27894

Position Type: Temporary

Required Skill Set:

Database, FDA, Filing, Regulatory Affairs, Technical, Tracking

Position Description:

**C2C is not available**
**Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.**
Job Title: Regulatory Affairs Associate I
Location: Wilson, NC
Duration: 11+ Months


Description:

Job Purpose:
• Contributes to the preparation and submission of regulatory filing documents.
• Monitors and tracks information and requirement changes.

Major Accountabilities:
• Provides assistance to members of the RA team in the compilation of AN- DAs, 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.

Discretion/Latitude:
• Work is closely supervised.
• Follows specific, detailed instructions.

Impact:
• Contributes to the completion of routine technical tasks.
• Failure to achieve results can normally be overcome without serious effect on schedules and programs.

Liaison:
• Contacts are primarily with immediate supervisor, project leaders, and other professionals in the section or group.

Education:
• Bachelor''s degree in a scientific related field.

Experience:
• No significant related experience.

Required Skills:
• Regulatory Affairs.
• ANDA.
• DAS.
• Databases.
• FDA.
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Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.)
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