MyKelly
Regulatory Affairs Associate
Kansas City, Missouri
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Regulatory Affairs Associate – Kansas City, MO
Responsibilities
- Prepares, compiles, reviews, and finalizes regulatory applications for submissions of original ANDAs, supplements, deficiency responses/amendments, and Annual Reports
- Prepares, reviews, and validates XML files to execute electronic submissions to the FDA
- Creates, revises and reviews labeling per current FDA requirements
- Tracks, renews, and completes new state licensing applications based upon requirements of each state
- Interacts with other functional department to coordinate and facilitate quality and timely submissions
- May represent Regulatory Affairs at designated meetings
- Maintains electronic and physical files of all documents received and generated by the Regulatory Department
- Maintains tracking of various filings and other distinct regulatory reports to ensure workflow through the department and satisfactorily meeting external and internal deadlines
- Comprehends current knowledge base & keeps abreast of new regulations, standards, or guidance documents
- Performs other duties as assigned
Qualifications
- Bachelor’s Degree with emphasis on Pharmaceutical, Chemistry, Biologic Science, or a related field
- 2 years related experience required.
- Electronic filing experience
- Proficient in Microsoft Excel, Word. Rosetta, Gecco, and Fixmd5 preferred
- Excellent detail orientation and analytical skills
- Excellent communication skills and presentation skills
- Strong discretion of confidential matters and overall business ethics
Job Type: Contract to Hire
Shift: M-F 8a-5p
Pay Rate: 50-53K
For Immediate Consideration, Apply Today! For more information contact Toni at 714 454 8252 / [email protected], or schedule a time to connect @ https://calendly.com/tonm369/interview
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