Advisor-R&D

Location: Indianapolis

### Job Details####

Job Title:

Advisor-R&D  ####

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.×## 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-R&D| 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!*
* ** Your Role:
Advisor, CMC Regulatory Affairs - Biologicals
** As the Advisor, CMC Regulatory Affairs - Biologicals, you will provide strategic regulatory guidance to ensure comprehensive, cohesive, and compliant submissions that maintain global product registrations and availability. In this role, you will partner closely with Manufacturing, Quality, R&D, and regulatory authorities to deliver innovative regulatory solutions that support the Elanco pipeline and sustain established biological products.

** Your Responsibilities:*
* • Develop and execute regulatory CMC strategies to maintain veterinary biological product registrations and ensure product availability    
• Author and review scientifically sound, accurate, and compliant regulatory submissions in collaboration with cross-functional subject matter experts    
• Provide regulatory subject matter expertise to QC, QA, and Manufacturing, ensuring inspection readiness and regulatory compliance    
• Anticipate and resolve complex regulatory challenges, coordinate and review regulatory commitments, and lead commitment responses    
• Drive continuous improvement by building tools, systems, and business processes that enhance regulatory capabilities and foster innovation    
** What You Need to Succeed (minimum qualifications):**    •
*
* Education:

** Master's Degree required    •
*
* Experience:

** Minimum 8 years of experience within a veterinary vaccine or biological manufacturing environment    •
** Top

Skills:

** Strong regulatory CMC expertise and ability to work independently within cross-functional teams    
** What Will Give You a Competitive Edge (preferred qualifications):*
* • Strong understanding of global veterinary biological regulatory requirements (e.g., US FDA, EMA, and other international authorities)    
• Demonstrated experience interacting directly with regulatory agencies    
• Proven ability to influence cross-functional stakeholders and drive regulatory strategy    
• Experience supporting regulatory inspections and post-approval commitments    
• Excellent interpersonal and communication skills with the ability to build collaborative relationships    
** Additional Information:**    •
** Travel:
** Minimal to moderate, as required    •
*
* Location:

** Global Elanco Headquarters - Indianapolis, IN - Hybrid Work Environment    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

To apply please click on APPLY TO THIS POSITION Job Post Date: 03/04/26

Here are some other jobs you may be interested in applying for.|  |  || --- | --- || Elanco  Indianapolis, Indiana | Elanco  Indianapolis, Indiana || Elanco  Indianapolis, Indiana |  |14 people are interested in this job.
#J-18808-Ljbffr