Senior Director of Regulatory Affairs

Job Summary

To lead global regulatory strategies for oncology products, the full-time Senior Director of Regulatory Affairs will develop and implement strategies for securing IND/CTA approvals and provide regulatory leadership for global marketing applications, working remotely.

Key responsibilities

• Leads global regulatory strategies for assigned products through all phases of development
• Advises management and cross-functional teams on relevant laws, regulations, and guidelines affecting regulatory processes
• Expands therapeutic area knowledge and mentors regulatory team members while ensuring corporate goals are met

Required qualifications

• Bachelor's degree in life sciences; Master's or Doctorate preferred
• Minimum of 10+ years' experience in pharmaceutical regulatory activities, including lead regulatory product strategist roles in multiple major regions
• Experience with marketing/license applications (e.g., BLA, NDA, MAA)
• Minimum of 5+ years in a strategic leadership role with strong project management skills
• Experience interfacing with major government regulatory authorities