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Job Summary: 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. Reporting Relationships This position has no direct reportsEssential Functions:Review and provide feedback for Change Controls for Contract Manufacturing Organizations (CMOs) and internal manufacturing sites with supervisionReview and submit all US regulatory submissions Amendments/supplements, annual reports, etc. for products assigned to you with supervisionReview US Package Inserts, Patient Package Inserts and Medication Guides Review all documentation for completeness and accuracy within regulatory requirementsFollows standards for document preparation, timeline development, and procedures required for eCTD formatPerform regulatory research and regulatory intelligence as needed Responsible for data entry, filing, archiving, and maintenance of submission tracking databases.All other duties assigned by ManagerSpecialized Skills and Knowledge: B.S. in Pharmacy /Science (or related field) requiredMinimum 1-year Regulatory Affairs experience (Generic experience preferred)Key Competencies:1. Ability to communicate effectively on Regulatory strategies and opinion2. Detail oriented 3. Ability to work on multiple projects at a time4. Efficient in word, adobe, and excel Physical Demands/Factors:Work is primarily sedentary in nature; routine bending, walking, lifting and reaching are required.The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Based on the highly regulated workplace at Avet, employees will be required to meet minimum English proficiency requirements.All applicants must be legally authorized to work in the U.S. for any employer. We are unable to sponsor any applicants for a work visa or take over sponsorship of a work visa for any applicants, at this time.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.