Associate Director, Regulatory Affairs – Biologics

Elanco in; Greenfield (IN); On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Multiple relocation packages

Two weeklong shutdowns (mid-summer and

year-end) in the US (in addition to

8-week parental leave

9 Employee Resource Groups

Annual bonus offering

Flexible work arrangements

Up to 6% 401K matching

Job summary

Elanco is seeking an Associate Director, Regulatory Affairs – Biologics (Project Management) to lead regulatory strategy for biologics and vaccine programs across development and lifecycle management. You will partner with R&D, Manufacturing, Quality, and global regulatory stakeholders to ensure compliant, timely submissions.

The ideal candidate will have 5+ years in Regulatory Affairs within biologics or vaccines, strong cross-functional influence, and experience with regulatory submissions and

Qualifications

• Bachelor's degree in a scientific or technical discipline required.
• Minimum of 5 years of Regulatory Affairs experience within biologics, vaccines, biotechnology, or other regulated life sciences.
• Experience supporting regulatory strategy, submissions, health authority interactions, or agency responses.
• Knowledge of biologics development, manufacturing processes, and product lifecycle management.
• Ability to work cross-functionally and influence decisions in a matrixed environment.

Responsibilities

• Lead regulatory strategy for biologics and vaccine programs across development and lifecycle management.
• Serve as a primary regulatory contact for health authorities (FDA, USDA/CVB, EMA, and global agencies).
• Drive planning, preparation, and submission of regulatory dossiers, agency responses, and supporting documentation.
• Provide regulatory guidance on biologics development, manufacturing changes, tech transfer, and lifecycle management.
• Partner with R&D, Manufacturing, Quality, Technical Operations and other stakeholders to align regulatory strategy with program goals.

Skills

Regulatory Affairs

Cross-functional collaboration

Regulatory submissions

Communication

Education

Bachelor's degree in a scientific field

Job description

Associate Director, Regulatory Affairs – Biologics (Project Management)

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!

Your Role

As Associate Director, Regulatory Affairs – Biologics, you will lead regulatory strategy for biologics and vaccine programs supporting Animal Health innovation. This role guides regulatory activities across development and lifecycle management, partnering closely with R&D, Manufacturing, Quality, Technical Operations, and global regulatory stakeholders.

The ideal candidate brings experience in biologics, vaccines, biotechnology, or pharmaceutical regulatory affairs and has supported regulatory strategy, health authority interactions, and regulatory submissions. Experience in Animal Health is valued but not required.

This is an opportunity to apply your biologics regulatory expertise to innovative development programs while helping advance products that improve animal health globally.

Your Responsibilities

• Lead regulatory strategy for biologics and vaccine programs across development and lifecycle management activities
• Serve as a primary regulatory contact for interactions with health authorities, including FDA, USDA/CVB, EMA, and other global agencies
• Drive planning, preparation, and submission of regulatory dossiers, agency responses, and supporting documentation
• Provide regulatory guidance on biologics development, manufacturing changes, tech transfer, and lifecycle management
• Partner with R&D, Manufacturing, Quality, Technical Operations, and other stakeholders to align regulatory strategy with program goals

What You Need to Succeed (minimum qualifications)

• Education: Bachelor's degree in a scientific or technical discipline required
• Experience: Minimum of 5 years of Regulatory Affairs experience within biologics, vaccines, biotechnology, pharmaceutical, or other regulated life science environments
• Experience supporting regulatory strategy, regulatory submissions, health authority interactions, or agency responses
• Knowledge of biologics development, manufacturing processes, and product lifecycle management
• Ability to work cross-functionally and influence decisions in a matrixed environment

What Will Give You a Competitive Edge (preferred qualifications)

• Experience in Animal Health, Veterinary Biologics, Veterinary Vaccines, or related regulatory environments
• Experience in Biologics CMC Regulatory Affairs
• Familiarity with USDA-CVB, FDA-CVM, EMA, and VICH regulatory requirements
• Experience supporting manufacturing changes, tech transfer, or post-approval regulatory activities
• Experience supporting global or multi-regional regulatory programs

Elanco Benefits and Perks:

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:

• 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

Full-time equivalent employees also will be eligible for a company bonus (depending partly on company and individual performance). Additionally, Elanco offers a comprehensive benefit program to eligible employees that includes a company-matching 401(k); vacation benefits; eligibility for medical, dental, vision, and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Elanco reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion, and Elanco's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Elanco employees.

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 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.