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 reports

Essential Functions:

• Review and provide feedback for Change Controls for Contract Manufacturing Organizations (CMOs) and internal manufacturing sites with supervision
• Review and submit all US regulatory submissions Amendments/supplements, annual reports, etc for products assigned to you with supervision
• Review US Package Inserts, Patient Package Inserts and Medication Guides
• Review all documentation for completeness and accuracy within regulatory requirements
• Follows standards for document preparation, timeline development, and procedures required for eCTD format.
• Perform regulatory research and regulatory intelligence as needed
• Responsible for data entry, filing, archiving, and maintenance of submission tracking databases.
• All other duties assigned by Manager.

Specialized Skills and Knowledge:

• B.S. in Pharmacy /Science (or related field) required
• Minimum 1 years Regulatory Affairs experience (Generic experience preferred

Key Competencies:

1. Ability to communicate effectively on Regulatory strategies and opinion

2. Detail oriented

3. Ability to work on multiple projects at a time

4. Efficient in word, adobe, and excel

Physical Demands/Factors:

Work is primarily sedentary in nature; routine bending, walking, lifting and reaching are required.

At Avet, we require that all employees physically entering the workplace to be fully vaccinated against COVID-19, and you will be asked to present proof of vaccination before beginning employment unless you quality for a reasonable accommodation based on a sincerely held religious belief or medical need.

Based on the highly regulated workplace at Avet, employees will be required to meet minimum English proficiency requirements.

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