Advisor - Global Regulatory Affairs CMC Biologicals

Indiana Ag Connection; Indianapolis (IN); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Relocation packages

Shutdowns mid-summer

Parental leave

Employee Resource Groups

Annual bonus

Flexible work arrangements

401K matching

Job summary

Elanco Indianapolis is seeking an Advisor, Global Regulatory Affairs - CMC Biologicals to drive regulatory submissions and maintain product registrations for animal health vaccines. A Master’s degree with 8+ years in veterinary vaccine manufacturing is required, with deep knowledge of US FDA and international regulations.

You will lead cross‑functional teams across Manufacturing, QA, and R&D, develop strategies, and ensure inspection readiness while delivering compliant, timely regulatory

Qualifications

• Master's degree at minimum
• 8+ years in veterinary vaccine/biological manufacturing
• Strong knowledge of regulatory requirements (FDA/EMA) and product registrations

Responsibilities

• Provide regulatory guidance to support submissions and product availability
• Lead cross-functional teams incl. Manufacturing, QA, R&D
• Prepare and review submissions ensuring scientific accuracy and compliance
• Coordinate replies to regulatory authorities and inspections readiness

Skills

Regulatory strategy

Cross-functional leadership

Technical writing

Communication skills

Education

Master's degree

Tools

Regulatory databases

Job description

### Job Details#### Job Title:Advisor - Global Regulatory Affairs CMC Biologicals#### Location:,, ,#### Company:#### Industry Sector:#### Industry Type:#### Career Type:#### Job Type:Full Time#### Minimum Years Experience Required:N/A#### Salary:### Get Job Alerts**Career Type:****Country:** USAI agree to receive alerts from and to the .Your alert was created successfully.x## General Alert Saved* The listings below are jobs matching the criteria you've selected for your General Alert on.Criteria selected was:* General alert saved for .* General alert notifications will be sent weekly on Monday.* Please note that you can only have one general alert active at any given time. Creating a new general alert will override an existing general alert.* Visit the to manage your alerts# Advisor - Global Regulatory Affairs CMC Biologicals| Number of Years Experience: | Minimum Education Completed: | || Education Major / Discipline Category: | Most Recent / Current Occupation: | |**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.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 settingAdditional Preferences:* Strong understanding of varied regulatory requirements (e.g., US FDA, EMA, etc.) related to veterinary biological manufacturing.**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 matchingElanco 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.#LI-RH1Elanco 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 statusElanco 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.To apply please click on APPLY TO THIS POSITIONJob Post Date: 10/22/26Here are some other jobs you may be interested in applying for.| | || - | - || Elanco Indianapolis, Indiana | Elanco Indianapolis, Indiana || Elanco Indianapolis, Indiana | |4 people are interested in this job.