Advisor-R&D

Role Summary

As the Advisor, CMC Regulatory Affairs – Biologicals, you will provide strategic regulatory guidance to ensure comprehensive, cohesive, and compliant submissions that maintain global product registrations and availability. In this role, you will partner closely with Manufacturing, Quality, R&D, and regulatory authorities to deliver innovative regulatory solutions that support the Elanco pipeline and sustain established biological products.

Responsibilities

• Develop and execute regulatory CMC strategies to maintain veterinary biological product registrations and ensure product availability
• Author and review scientifically sound, accurate, and compliant regulatory submissions in collaboration with cross-functional subject matter experts
• Provide regulatory subject matter expertise to QC, QA, and Manufacturing, ensuring inspection readiness and regulatory compliance
• Anticipate and resolve complex regulatory challenges, coordinate and review regulatory commitments, and lead commitment responses
• Drive continuous improvement by building tools, systems, and business processes that enhance regulatory capabilities and foster innovation

Qualifications

• Required: Education: Master’s Degree required
• Required: Experience: Minimum 8 years of experience within a veterinary vaccine or biological manufacturing environment
• Required: Top Skills: Strong regulatory CMC expertise and ability to work independently within cross-functional teams
• Preferred: Strong understanding of global veterinary biological regulatory requirements (e.g., US FDA, EMA, and other international authorities)
• Preferred: Demonstrated experience interacting directly with regulatory agencies
• Preferred: Proven ability to influence cross-functional stakeholders and drive regulatory strategy
• Preferred: Experience supporting regulatory inspections and post-approval commitments
• Preferred: Excellent interpersonal and communication skills with the ability to build collaborative relationships

Additional Requirements

• Travel: Minimal to moderate, as required
• Location: Global Elanco Headquarters – Indianapolis, IN – Hybrid Work Environment