Overview

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals’ lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco’s promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

 

Position Description:

  • Represent the Regulatory US Affiliate to ensure regulatory compliance and timely submissions for post-approval regulatory activities related to pharmaceutical (FDA-CVM) product labeling, advertising and promotion, and other assigned areas of responsibility.  Additionally, demonstrate leadership by providing innovative solutions, promoting a positive work environment, and effectively communicating to ensure delivery and maintenance of Elanco’s food animal and pet health pharmaceutical portfolio.

 

Functions, Duties, Tasks:

  • Maintain a broad overview of all post-approval activities related to assigned products and/or areas of responsibility
  • Provide regulatory guidance in the generation and approval of post-approval labeling changes as an Associate Labeling Responsible Person (ALRP) for the US Affiliate, and submit label updates to FDA-CVM
  • Provide regulatory guidance in the development and approval of promotional materials for the Elanco US Affiliate to support the food animal and pet health marketed pharmaceutical products and new launches
  • Support post-approval CMC updates, periodic reports and other post-approval submissions to FDA-CVM.  This may include but is not limited to compilation, submission and archival
  • Collaborate with other functional areas (Global CMC, Marketing, Legal, Technical, Labeling, Supply Chain, Quality, etc.) and external partners to promote regulatory awareness of and compliance with applicable regulations and internal policies and procedures
  • Represent Elanco in direct communications with FDA-CVM, in written form and by attending meetings as required by the project
  • Maintain positive business collaboration and influence with Elanco US Affiliate and FDA-CVM
  • Perform other related duties and assignments as required by the business and directed by management

 

Minimum Qualification (education, experience and/or training, required certifications):

  • Bachelor’s degree or equivalent with at least 3 years relevant work experience within the sciences or related areas

 

Additional Preferences:

  • Understanding of US FDA-CVM regulatory requirements, particularly those related to labeling, advertising and promotion
  • Self-management skills in an environment with diverse needs and demanding timelines
  • Strong oral and written communication skills and attention to detail

 

Other Information:

  • Domestic and international travel, up to 5%

 

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

Tagged as: EARLY CAREER, MID TO SENIOR LEVEL

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