Global Regulatory Strategy Leader

BioSpace; Indianapolis (IN); On-site; USD 170,000 - 249,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Health benefits

Job summary

Lilly seeks a Global Regulatory Lead to guide global regulatory strategies from portfolio entry through end of life. You will provide strategic and technical leadership to a cross-functional Global Regulatory Team and own the interaction strategy with the US FDA.

The role is based in Indianapolis, IN or Boston Harborside, with 10–15% travel. Advanced degree and 8+ years in regulatory affairs are required; a Bachelor’s or Master’s with 10+ years is also acceptable.

Qualifications

• Advanced scientific degree (PharmD or PhD) with regulatory focus.
• 8+ years of experience in regulatory affairs and/or drug development.
• Bachelor’s or Master’s degree with 10+ years in regulatory affairs and/or drug development.

Responsibilities

• Develop and execute global regulatory strategies from entry through lifecycle.
• Oversee US FDA submissions (INDs, NDAs, BLAs) and agency interactions.
• Lead cross-functional global regulatory team and mentor personnel.
• Manage external engagement with key regulatory authorities and stakeholders.

Skills

Regulatory leadership

FDA interactions

Cross-functional leadership

Regulatory strategy

Education

PharmD/PhD

Bachelor’s/Master’s +10 yrs

Job description

Lilly seeks a Global Regulatory Lead to guide global regulatory strategies from portfolio entry through end of life. You will provide strategic and technical leadership to a cross-functional Global Regulatory Team and own the interaction strategy with the US FDA.

The role is based in Indianapolis, IN or Boston Harborside, with 10–15% travel. Advanced degree and 8+ years in regulatory affairs are required; a Bachelor’s or Master’s with 10+ years is also acceptable.