The primary responsibility for the position is to manage the Regulatory Affairs team members. Ensure that deliverables are being met based on planned submission timelines. Provide training for Regulatory Team based on department needs and new FDA Guidance. Review and approve the necessary aspects involved with the preparation of all regulatory submissions including ANDA/NDAs, amendments, supplements and annuals reports. The individual will manage all filings for the New Jersey facility and CMOs.
This position has 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 ANDA/NDAs, amendments/supplements, annual reports, etc.
• Develop Regulatory Strategies
• Review US 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.
• Understand submission timelines and ensure team is meeting timelines
• Assess department needs for training and provide training to team members
Specialized Skills and Knowledge:
• Prior Managerial experience required.
• B.S. in Pharmacy /Science (or related field) required
• Minimum 8-10 years Generic Regulatory Affairs 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; there are no special physical demands.
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
|Job Category||Regulatory Affairs|