Director, Regulatory Affairs Strategy - Oncology

The Director, Regulatory Affairs Strategy - Oncology will provide leadership on global regulatory activities for assigned products, focusing on Clinical Regulatory filings and project teams. Responsibilities include providing regulatory leadership, interpreting regulatory authorities' feedback, and preparing major clinical submissions. The role requires strong understanding of US FDA and international pharmaceutical guidance, regulations, and industry standard practices, as well as excellent written and verbal communication skills.

Requirements

• MD, Ph.D., or Pharm D. degree
• Minimum of 10 years of pharmaceutical industry experience
• At least 7 years of regulatory experience
• Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills
• High attention to detail and ability to coordinate and prioritize assigned projects

Benefits

• Health and wellness programs
• 401(k) company match
• Family support benefits
• Equity awards
• Annual bonuses
• Paid time off
• Paid leaves (e.g., military and parental leave)