Global Regulatory Strategy Lead

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

Benefits offered by this job

Relocation assistance

Annual bonus

Comprehensive benefits

Travel support

Job summary

Lilly, headquartered in Indianapolis, Indiana, seeks a Global Regulatory Lead to develop and execute global regulatory strategies and to own interactions with the US FDA. You will lead a cross-functional team, interact with the Global Brand Development team, and own regulatory plans across lifecycles.

Travel 10-15% is expected. Minimum qualifications include an advanced scientific degree with 8+ years in regulatory affairs or a Bachelor's/Master's with 10+ years of experience.

Qualifications

• Advanced degree with 8+ years of regulatory affairs and/or drug development.
• Bachelor's or Master's with 10+ years of regulatory experience accepted.
• Deep knowledge of global regulatory procedures and agency interactions.

Responsibilities

• Develop and execute global regulatory strategies, owning the strategy document from candidate selection through lifecycle.
• Oversee US FDA submissions and agency interactions, including INDs, NDAs, and BLAs.
• Lead cross-functional Global Regulatory Team and mentor personnel.
• Engage with external stakeholders to shape regulatory environment and promotional strategy.

Skills

Regulatory strategy

FDA interactions

Education

Advanced scientific degree (PhD/ PharmD)

Bachelor's or Master's with 10+ years

Job description

Lilly, headquartered in Indianapolis, Indiana, seeks a Global Regulatory Lead to develop and execute global regulatory strategies and to own interactions with the US FDA. You will lead a cross-functional team, interact with the Global Brand Development team, and own regulatory plans across lifecycles.

Travel 10-15% is expected. Minimum qualifications include an advanced scientific degree with 8+ years in regulatory affairs or a Bachelor's/Master's with 10+ years of experience.