Advisor – Global Regulatory Affairs CMC Biologicals

Elanco • Indianapolis, IN

13d

About The Position

The Advisor, CMC Regulatory Affairs – Biologicals provides regulatory guidance to support comprehensive, cohesive, and compliant submissions and interactions, helping maintain product registrations and product availability. The role interacts with regulators and internal stakeholders to develop regulatory solutions, initiate strategies, and follow up on process improvements and commitments. It develops relationships with internal and external stakeholders, including Manufacturing, Quality, R&D, third parties, and trade associations.

The position provides technical and leadership contributions to deliver the Elanco pipeline and maintain established registrations and regulatory availability. It works independently within cross-functional teams, advises Quality Control, Quality Assurance, and Manufacturing on regulatory matters, supports inspection readiness, and develops tools, systems, and processes. It also writes and reviews scientifically sound, accurate, and compliant submissions in collaboration with subject matter experts, and coordinates, supervises, and reviews commitment responses. The role promotes continuous improvement, innovative regulatory solutions, collaboration, and an engaging work environment.

Requirements

• Master’s degree at a minimum.
• At least 8 years in a veterinary vaccine or biological manufacturing setting.
• Thorough understanding of applicable regulations sufficient to work independently within a cross-functional team.
• Excellent interpersonal and communication skills.

Nice To Haves

• Strong understanding of varied regulatory requirements related to veterinary biological manufacturing, such as US FDA and EMA requirements.

Responsibilities

• Provide regulatory guidance for comprehensive, cohesive, and compliant submissions and interactions to maintain product registrations and availability.
• Interact with regulators and internal stakeholders to drive regulatory solutions.
• Initiate strategies and follow up on process improvements and commitments.
• Build relationships with internal and external stakeholders, including Manufacturing, Quality, R&D, third parties, and trade associations.
• Work independently within cross-functional teams and anticipate and resolve complex problems to maintain products on the market.
• Advise Quality Control, Quality Assurance, and Manufacturing on regulatory aspects.
• Ensure inspection readiness from a regulatory perspective.
• Build tools, systems, and business processes to develop organizational capabilities.
• Write and review submissions for scientific soundness, accuracy, and compliance in collaboration with subject matter experts.
• Coordinate, supervise, and review commitment responses.
• Participate in meetings that drive strategy and outcomes.
• Identify continuous-improvement opportunities and facilitate implementation of new standards and practices.
• Deliver regulatory solutions and opportunities while fostering an innovative culture.
• Collaborate flexibly across Elanco teams, external collaborators, government agencies, and affiliates to achieve company deliverables.
• Create a positive, engaging, and inspiring work environment aligned with company objectives.
• Influence others to consider different perspectives and identify essential wins.

Benefits

• Multiple relocation packages.
• Two weeklong shutdowns in the US, mid-summer and year-end, in addition to PTO.
• 8-week parental leave.
• 9 Employee Resource Groups.
• Annual bonus offering.
• Flexible work arrangements.
• Up to 6% 401K matching.
• Comprehensive benefits package focused on financial, physical, and mental well-being.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior