Associate Director, Regulatory Liaison – Oncology

Responsibilities

• Supports products in the Oncology therapeutic area as part of a regulatory team
• Work closely with a global regulatory lead(s) to help develop and implement a global strategy for registration and/or maintenance of products
• Assisting in Regulatory Agency communications and submissions, including marketing applications, investigational new drug (IND) applications, pediatric plans and annual or other periodic reports
• Implementing strategy to develop Agency background packages and documents associated with regulatory submissions for marketing applications
• Communicating with Agencies and attending Agency meetings as needed
• Participating as an active member on the global regulatory team
• Conducting research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy
• Assisting with process improvement initiative
• Performing regulatory administrative activities, as needed

• M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline
• Master’s Degree with at least 2 years of relevant experience in pharmaceutical industry
• Bachelor’s Degree, with at least 5 years of relevant experience in the pharmaceutical industry
• Experience in drug development
• Prior regulatory experience interacting with a major regulatory agency
• Excellent communication skills (both oral and written)
• Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects
• Flexibility required
• Strong scientific and analytical skills with attention to detail