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Assoc Cnslt-Regulatory Affairs at Elanco in greenfield, Indiana

Posted in General Business 30+ days ago.

Type: Full-Time

Job Description:

Interested in joining a cause-driven, customer focused company dedicated to positively impacting the health of animals, people and the planet? Search our job listings below.


The purpose of the Regulatory Consultant position is to provide sound regulatory advice in support of licensing, compliance, and post-approval maintenance efforts at Elanco. This position will be responsible for planning and preparing regulatory submissions, reviewing regulatory documents, communicating with the USDA-CVB, maintaining regulatory databases, and interacting with cross-functional teams to gain alignment on submission strategies.  

Job responsibilities:

Key Technical Responsibilities:

  • Provide regulatory guidance to result in comprehensive, cohesive, and compliant submissions.

  • Review submissions to ensure they are scientifically sound, accurate, and compliant.

  • Coordinate, supervise, and review commitment responses to assist in timely submissions.

  • Disseminate pertinent regulations to the appropriate persons/departments when required or first published, and provide clarifications when/if needed.

  • Prepare regulatory submissions, including cover letter to the authority.

  • Responsible for having an understanding of the regulations in order to work independently within a cross-functional team

Key Leadership Responsibilities:

  • Ability to work independently, effectively, and flexibly within and across all Elanco RA, R&D, Manufacturing, Quality, and Marketing teams, as well as external collaborators and agencies, to assist in achieving Elanco registration deliverables.

  • Proactively search for regulatory solutions.

  • Accept challenges in order to deliver innovative registration solutions and create an innovative culture.

  • Create a positive work environment that is aligned with company objectives.

  • Create an engaging culture with “play to win” mentality.

  • Identify and utilize methods to deliver individual objectives in a high quality, timely, and cost-effective manner.

Basic Minimum Qualifications:

  • Bachelor Degree in Biological Sciences with 5 years industry experience. 

  • Working knowledge in immunology

  • Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

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



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