Global Regulatory Lead: Strategy, FDA Leadership
Eli Lilly and Company
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Benefits offered by this job
Job summary
Eli Lilly and Company is seeking a Global Regulatory Lead to guide regulatory strategy from portfolio entry through end of life and to lead a cross-functional team including GRA-CMC, GRA-Devices, and GRA-RD&E. The role includes ownership of interactions with the US FDA and alignment with global development plans.
The position requires an advanced scientific degree with 8+ years in regulatory affairs or drug development and travel of 10–15%.
Qualifications
- Advanced degree in a relevant science with 8+ years in regulatory affairs or drug development.
- Proven ability to lead cross-functional teams and drive regulatory strategy.
- Experience with US FDA submissions and global regulatory interactions.
- Strong leadership and stakeholder communication at executive level.
Responsibilities
- Develop and execute global regulatory strategies from candidate selection through lifecycle.
- Oversee US FDA submissions and agency interactions, ensuring clear scientific positions.
- Lead a cross-functional Global Regulatory Team and mentor personnel.
- Engage external stakeholders to shape regulatory environment and promotional strategy.
Skills
Education
Job description
Eli Lilly and Company is seeking a Global Regulatory Lead to guide regulatory strategy from portfolio entry through end of life and to lead a cross-functional team including GRA-CMC, GRA-Devices, and GRA-RD&E. The role includes ownership of interactions with the US FDA and alignment with global development plans.
The position requires an advanced scientific degree with 8+ years in regulatory affairs or drug development and travel of 10–15%.
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