Job Summary

An information technology consultancy is seeking a Remote Regulatory Affairs Manager in Madison.

Individual must be able to fulfill the following responsibilities:

• Carry out managerial responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws
• Direct, coordinate and prioritize the daily activities of the assigned staff
• Review and approve regulatory submissions (i.e. ANDAs, amendments, supplements, etc.) to the Food and Drug Administration

Required Skills:

• FDA, SOP and cGMP standards, guidelines and regulatory compliance regulations
• Pertinent Federal and State laws related to pharmaceutical regulatory affairs
• Supervision and training practices and methods
• Business, scientific and personal computer software applications
• Business English usage such as, spelling, grammar and punctuation