Advisor – Global Regulatory Affairs CMC Biologicals

Position Description

The Advisor, CMC Regulatory Affairs – Biologicals for Elanco Animal Health is responsible for providing regulatory guidance resulting in comprehensive, cohesive, and compliant submissions and interactions to maintain product registrations and product availability. The individual in this role interacts with regulators and internal stakeholders to drive regulatory solutions. The Advisor, CMC Regulatory Affairs – Biologicals will initiate strategies and follow-up on process improvements and commitments. Additionally, the individual in this role will focus on interacting positively while developing relationships with internal and external stakeholders including Manufacturing, Quality, R&D, and third party and trade association groups. The individual in this role is expected to perform key leadership responsibilities, which provide innovative solutions, a positive and motivating work environment, to ultimately deliver the Elanco pipeline and maintain established product registrations and regulatory availability.

Functions, Duties, Task: Key Technical Responsibilities

• Responsible for having a thorough understanding of the regulations to work independently within a cross-functional team.
• Anticipates and resolves complex problems to maintain product to market.
• Subject matter expertise to advise QC, QA, and Manufacturing on regulatory aspects.
• Ensure inspection readiness from regulatory perspective.
• Build tools, systems, and business processes to develop best capabilities.
• Writes and reviews submissions to ensure they are scientifically sound, accurate, and compliant in close collaboration with Subject Matter Experts.
• Coordinate, supervise and review commitment responses.
• Actively participates in meetings that drive strategy and outcomes.

Key Leadership Responsibilities

• Proactively search for opportunities for continuous improvement and facilitate implementation of new standards and practices with the ability to think “out of the box”.
• Deliver regulatory solutions and opportunities while creating an innovative culture.
• Work effectively and flexibly within and across all Elanco teams, external collaborators, government agencies, and affiliates to assist in achieving overall Elanco deliverables.
• Create a positive, engaging, and inspiring work environment that is aligned with company objectives.
• Influence others to adopt a different view to create an innovative culture.
• Create an engaging culture and identify essential wins.
• Excellent interpersonal and communication skills.

Minimum Qualification (education, experience and/or training, required certifications)

• Master’s degree at a minimum
• Minimum 8 years in a veterinary vaccine / biological manufacturing setting

Additional Preferences

Strong understanding of varied regulatory requirements (e.g., US FDA, EMA, etc.) related to veterinary biological manufacturing.