Compliance

• 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
• Participating as an active member on the global regulatory team and attending cross-functional meetings as required
• Conducting research and review of guidelines, regulatory precedence, and competitive intelligence to facilitate development of regulatory strategy
• Assisting the global regulatory lead in authoring of regulatory strategy documents
• Collaborating and communicating regulatory strategy to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC, and other functional areas
• Supporting maintenance (e.g., quality compliance and life cycle management) of oncology programs
• Support the global regulatory lead in label development
• Assisting with process improvement initiatives
• Performing regulatory administrative activities as needed.

Associate Principal Scientist, Regulatory Liaison

Senior Regulatory Risk Specialist

Director, Ethics and Compliance Investigations

Director, Global Regulatory Leader

Director, Global Regulatory Leader

Senior Manager, Quality – Regulatory Affairs