Global Regulatory CMC Lead

Eli Lilly and Company; Boston (MA); Híbrido; USD 168.000 - 268.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Bonus program

401(k) plan

Medical, dental, vision benefits

Descripción de la vacante

Eli Lilly and Company in the United States seeks an Advisor/Sr. Advisor - Global Regulatory Affairs (GRA) – CMC Platform Regulatory Scientist to provide strategic, tactical, and operational regulatory CMC support for clinical trials, market registrations, and post-approval activities.

Location: Indianapolis or Boston (hybrid). The role requires leadership in global CMC regulatory strategies and collaboration across research, development, manufacturing, quality, and regulatory teams to ensure

Formación

• Minimum of 5 years regulatory CMC experience within pharma or biotech.
• Strong written, spoken and presentation communication skills.
• Experience authoring CMC submission content preferred.
• Demonstrated negotiation and influence skills.

Responsabilidades

• Lead development and execution of global CMC regulatory strategies.
• Collaborate with manufacturing sites, technical experts, and quality teams to resolve issues.
• Support health authority interactions with briefing materials and responses.
• Provide regulatory guidance to enable informed development and lifecycle planning.

Conocimientos

Regulatory CMC experience

Cross-functional collaboration

Regulatory writing & submissions

Communication & leadership

Educación

Bachelor's degree in sciences (chemistry/biology/pharmacy)

Descripción del empleo

Eli Lilly and Company in the United States seeks an Advisor/Sr. Advisor - Global Regulatory Affairs (GRA) – CMC Platform Regulatory Scientist to provide strategic, tactical, and operational regulatory CMC support for clinical trials, market registrations, and post-approval activities.

Location: Indianapolis or Boston (hybrid). The role requires leadership in global CMC regulatory strategies and collaboration across research, development, manufacturing, quality, and regulatory teams to ensure