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 minimal supervision. The individual is responsible for ensuring submissions meet FDA requirements and internal timelines.
- This position has no direct reports
- Review and provide feedback for Change Controls for Contract Manufacturing Organizations (CMOs) and internal manufacturing sites
- Review and submit all US regulatory submissions ANDAs, amendments/supplements, annual reports, etc for products assigned to you
- Review US Labeling pieces including Labels, Package Inserts, Patient Package Inserts and Medication Guides
- Review all documentation for completeness and accuracy with regulatory requirements
- Follows standards for document preparation, timeline development, and procedures required for eCTD format.
- Perform regulatory research and regulatory intelligence as needed
- Chair submission team meetings and maintain/distribute updated submission plans, negotiate timings and coordinate deliverables with associated disciplines in support of major submissions and management objectives.
- Establish standards for document preparation, timeline development/management, and procedures to receive final, submission ready documents in eCTD format.
- 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 3 years Regulatory Affairs experience (Generic experience preferred)
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
Work is primarily sedentary in nature; routine bending, walking, lifting and reaching are required.
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.
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 qualify 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.
|Job Category||Regulatory Affairs|