Madison, NJ, USA
Posted by: Leo Pharma
14 Oct

Associate Director, US Regulatory Lead, Marketed Products Support

Madison, NJ, USA
Job Description

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.
Job ID Reference
Desired Skills & Experience

  • BA/BS degree in one of the life sciences required; advanced degree (M.S., Pharm.D., Ph.D,) preferred.
  • Minimum of 7 years of experience gained working in the Pharmaceutical/Biotechnology industry; experience working with biologics/biologic launch experience preferred
  • Minimum of 6 years’ experience in Regulatory Affairs or equivalent experience (i.e. completed an accredited Pharmaceutical Industry PharmD Fellowship Program in Regulatory Affairs)
  • Ability to multiple task, set priorities and meet critical deadlines
  • Direct experience working/collaborating with FDA on assigned products; (Dermatology Division experience considered a plus)
  • Expert knowledge of US and ICH regulations. 
  • Knowledge of clinical development required; knowledge of nonclinical, clinical pharmacology, biostatistics and CMC regulatory desirable.

  New York
LEO Pharma has embarked on a growth journey to become the preferred dermatology care partner in the world, dedicated to help people achieve healthy skin. We have an ambitious 2025 strategy, which aims to accelerate our impact in innovative therapeutics while strengthening our established portfolio and our global footprint in medical dermatology. Dermatology is an area of rapid growth and LEO Pharma´s vision is to reach 125 mill. patients worldwide by 2025. Our nimble and entrepreneurial environment allows passionate people to innovate and make a visible impact.
 Madison, NJ, USA