Global CMC Regulatory Lead – Peptides & Oligos

Regulatory Jobs; Indianapolis (IN); Vor Ort; USD 149.000 - 257.000; Vollzeit

Benefits dieser Stelle

401(k) plan

Pension

Medical, dental, vision benefits

Well-being programs

Zusammenfassung

Lilly, headquartered in Indianapolis, is seeking a Regulatory CMC leader to drive global regulatory strategy and submissions for synthetic peptides and oligonucleotides. The role integrates regulatory science with manufacturing processes to accelerate development and registrations.

The ideal candidate will bring 10+ years of Regulatory CMC experience, deep knowledge of global expectations, and a collaborative approach to cross-functional teams across geographies.

Qualifikationen

• Bachelor of Science in a science, engineering, or related STEM field; advanced degree preferred.
• 10+ years of Regulatory CMC experience supporting clinical development or commercialization of synthetic peptides, oligonucleotides, or related complex modalities.
• Experience authoring CMC submissions and interacting with Health Authorities.

Aufgaben

• Provide regulatory leadership across CMC development for synthetic peptides and oligonucleotides.
• Lead preparation, critical review, and approval of CMC documentation for global regulatory submissions and responses.

Kenntnisse

CMC regulatory leadership

Global regulatory knowledge

Regulatory strategy

Cross-functional collaboration

Regulatory writing

Ausbildung

B.S. in science/engineering or related STEM

Advanced degree preferred

Jobbeschreibung

Lilly, headquartered in Indianapolis, is seeking a Regulatory CMC leader to drive global regulatory strategy and submissions for synthetic peptides and oligonucleotides. The role integrates regulatory science with manufacturing processes to accelerate development and registrations.

The ideal candidate will bring 10+ years of Regulatory CMC experience, deep knowledge of global expectations, and a collaborative approach to cross-functional teams across geographies.