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Due to the growth of the business, our Edison, NJ based client is seeking a top notch Senior Manager of Regulatory Affairs.
Excellent salary, benefits and relocation package are all included!
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 Guidances. Review and approve the necessary aspects involved with the preparation of all regulatory submissions including ANDAs, 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 ANDAs, 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