Director, Global CMC Regulatory & Lifecycle Innovation

Regulatory Jobs; Indianapolis (IN); Presencial; USD 177.000 - 282.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

401(k) plan

Comprehensive benefits

Descripción de la vacante

Lilly in Indianapolis seeks a Director, GRA-CMCD Lifecycle Innovation to lead regulatory science, strategy, and execution for post-approval CMC activities across parenteral products. You will partner with manufacturing, quality, and global teams to shape lifecycle plans, manage submissions, assess risks, and drive continuous improvement including digital tools.

This role requires deep knowledge of global CMC regulations, strong leadership, and the ability to influence at sites and with CMOs to

Formación

• BS in a STEM field required.
• 7+ years of Regulatory CMC or technical CMC experience.
• Advanced degree preferred (MS/PhD/PharmD).
• Experience with biologics, parenteral products, or combination products.

Responsabilidades

• Provide regulatory leadership for post-approval CMC activities across products/sites.
• Develop and implement lifecycle regulatory strategies and filing approaches.
• Lead submissions, variations, DMFs, and annual reports for global markets.
• Assess risks and apply GMP/CMC regulatory guidance to projects.
• Mentor and lead regulatory scientists and teams across sites and CMOs.
• Collaborate with Manufacturing, Quality, and Global regulatory peers.

Conocimientos

Regulatory CMC leadership

Lifecycle management

Regulatory strategy

Cross-functional leadership

Regulatory advisory

Risk assessment

Communication and influencing

Mentoring/regulatory teams

Educación

B.S. in STEM

Advanced degree preferred

Descripción del empleo

Lilly in Indianapolis seeks a Director, GRA-CMCD Lifecycle Innovation to lead regulatory science, strategy, and execution for post-approval CMC activities across parenteral products. You will partner with manufacturing, quality, and global teams to shape lifecycle plans, manage submissions, assess risks, and drive continuous improvement including digital tools.

This role requires deep knowledge of global CMC regulations, strong leadership, and the ability to influence at sites and with CMOs to