Compliance

• Supporting products in the Oncology therapeutic area as part of a regulatory team
• 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 to assist the global regulatory lead
• Conducting research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy
• Collaborating and communicating regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) as well as other functional areas
• Supporting maintenance (e.g., quality compliance and life cycle management) of oncology programs

Associate Director – Regulatory Liaison, Oncology

Senior Regulatory Risk Specialist

Director, Ethics and Compliance Investigations

Director, Global Regulatory Leader

Director, Global Regulatory Leader

Senior Manager, Quality – Regulatory Affairs