Job Summary

A global group of pharmaceutical companies is seeking a Remote US Regulatory Affairs Oncology Associate Director in Ridgefield.

Core Responsibilities of this position include:

• Providing US strategic regulatory guidance to facilitate efficient and compliant drug development and product maintenance
• Acting as primary company liaison with the US Food and Drug Administration
• Providing expertise on regulatory standards and departmental policies

Required Skills:

• Bachelors Degree in life scienc es, pharmacy, or chemistry from an accredited institution with drug development experience and knowledge
• Two (2) years of experience in Pharma/BIO industry
• Extensive experience demonstrated in managing all aspects of FDA liaison activities (e.g., submission strategies, FDA meeting “management”, AdComm participation/leadership)
• Relevant US regulatory experience and knowledge, from both strategic and operational perspectives
• Demonstrated basic understanding of BI processes and culture
• Demonstrated Medical, pharmaceutical and scientific knowledge and understanding in the assigned therapeutic area