Advisor – Global Regulatory Affairs CMC Biologicals

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

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today!

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.

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

• 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.

Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

Elanco Benefits and Perks

• Multiple relocation packages
• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401K matching

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.