Global Regulatory Affairs CMC Biologics Advisor

Indiana Ag Connection; Indianapolis (IN); Presencial; USD 140.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Relocation packages

Shutdowns mid-summer

Parental leave

Employee Resource Groups

Annual bonus

Flexible work arrangements

401K matching

Descripción de la vacante

Elanco Indianapolis is seeking an Advisor, Global Regulatory Affairs - CMC Biologicals to drive regulatory submissions and maintain product registrations for animal health vaccines. A Master’s degree with 8+ years in veterinary vaccine manufacturing is required, with deep knowledge of US FDA and international regulations.

You will lead cross‑functional teams across Manufacturing, QA, and R&D, develop strategies, and ensure inspection readiness while delivering compliant, timely regulatory

Formación

• Master's degree at minimum
• 8+ years in veterinary vaccine/biological manufacturing
• Strong knowledge of regulatory requirements (FDA/EMA) and product registrations

Responsabilidades

• Provide regulatory guidance to support submissions and product availability
• Lead cross-functional teams incl. Manufacturing, QA, R&D
• Prepare and review submissions ensuring scientific accuracy and compliance
• Coordinate replies to regulatory authorities and inspections readiness

Conocimientos

Regulatory strategy

Cross-functional leadership

Technical writing

Communication skills

Educación

Master's degree

Herramientas

Regulatory databases

Descripción del empleo

Elanco Indianapolis is seeking an Advisor, Global Regulatory Affairs - CMC Biologicals to drive regulatory submissions and maintain product registrations for animal health vaccines. A Master’s degree with 8+ years in veterinary vaccine manufacturing is required, with deep knowledge of US FDA and international regulations.

You will lead cross‑functional teams across Manufacturing, QA, and R&D, develop strategies, and ensure inspection readiness while delivering compliant, timely regulatory