Global Regulatory Affairs CMC Biologics Lead

Elanco; Indianapolis (IN); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Multiple relocation packages

Two weeklong shutdowns (mid-summer and

year-end) in the US (in addition to P

8-week parental leave

9 Employee Resource Groups

Annual bonus offering

Flexible work arrangements

Up to 6% 401K matching

Job summary

Elanco is a global animal health leader seeking a senior Advisor, CMC Regulatory Affairs – Biologicals. The role focuses on regulatory guidance, submissions, and interactions to maintain product registrations and availability. Collaboration with Manufacturing, Quality, R&D, and external partners is essential.

The position emphasizes leadership responsibilities, continuous improvement, and delivering regulatory solutions within a dynamic team environment at Elanco.

Qualifications

• Master’s degree required.
• Minimum 8 years in veterinary vaccine/biological manufacturing setting.
• Strong understanding of varied regulatory requirements (US FDA, EMA, etc.).

Responsibilities

• Drive regulatory guidance for cohesive submissions and interactions to maintain product registrations.
• Lead strategy development and follow-up on process improvements and commitments.
• Coordinate with Manufacturing, Quality, R&D and external groups to ensure regulatory readiness.

Skills

Regulatory affairs

Cross-functional collaboration

Leadership

Education

Master’s degree

Job description

Elanco is a global animal health leader seeking a senior Advisor, CMC Regulatory Affairs – Biologicals. The role focuses on regulatory guidance, submissions, and interactions to maintain product registrations and availability. Collaboration with Manufacturing, Quality, R&D, and external partners is essential.

The position emphasizes leadership responsibilities, continuous improvement, and delivering regulatory solutions within a dynamic team environment at Elanco.