Associate Director US Regulatory Lead, Marketed Product will provides US regulatory strategy to global teams for US marketed products as the basis for product labeling, annual reports, safety updates and other relevant documents necessary to maintain license to operate. In addition, you will be responsible for managing, and maintaining US INDs and NDAs marketed and oversight for these regulatory submissions. You will also act as the Regulatory Affairs representative in U.S. Regulatory Affairs for FDA interactions (communications and meetings) for U.S. Marketed products.
Your contribution to the team would include:
- Works with global and local teams to resolve project issues.
- Provide regulatory knowledge of regulations to strategically interpret, plan, and communicates requirements to ensure health authority approvals
- Accountable for driving US input into the Global regulatory strategic plans and risk-assessments US for assigned marketed product(s).
- Builds and aligns on the execution of regulatory strategies with key stakeholders in the US (marketing, Quality, Medical Affairs, Legal, Market Access, Safety,) and ensure regulatory compliance
- Ensures regulatory submissions are of high quality and submitted in a timely manner;
- Reviews regulatory filings for accuracy, completeness, and compliance with applicable regulatory requirements and internal procedures.
- Ensures key messages are clear and consistent within and across documents.
- Ensures fulfillment of commitments made to various health agencies (e.g., IND/NDA/MAA pediatric and post-marketing commitments, and others).
- Primary regulatory liaison with the FDA on all product related activities and marketed product as relevant.
- Provide US RA assessment/evaluations for due diligence activities supporting the US business.
