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Associate-Regulatory Affairs - United States  

Lilly (company)


Posted on : 23 May 2017

Project Description

Company Overview  
  • Our company is a global research-based company that develops and delivers product and services to enhance animal health and production. 
  • We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees

  •  The Regulatory Affairs Associate performs key functions within the company Regulatory Affairs unit for veterinary vaccines. 
  • The individual provides manufacturing site regulatory support by coordinating, preparing, and tracking regulatory submissions/responses.

Functions, Duties, Task:
Key Technical Responsibilities:
  • Knowledge of USDA regulations while remaining up-to-date on regulation changes.
  • Provide regulatory guidance to result in comprehensive, cohesive, and compliant submissions.
  • Maintain, update, and submit USDA required documents as directed by Manager; such as product labels. 
  • Administer department databases required for accurate tracking of registrations and/or commitments. 

Key Leadership Responsibilities
  • Proactively search for solutions.Work independently, effectively, and flexibly within and across all company RA, R&D, Manufacturing, Quality, and Marketing teams, as well as external collaborators and agencies, to assist in achieving company  registration deliverables.
  • Provide and accept challenge to deliver innovative technical 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 Qualifications
  • Bachelor Degree in Biological Sciences or at least 10 years’ experience in veterinary biologics industry.
  • Qualified candidates must be legally authorized to be employed in the United States. 
  • Our company  does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.   

Additional Skills/Preferences  
  • Proficient computer skills and expertise in basic Microsoft Office programs.
  • Ability to multi-task, prioritize and manage timelines. 
  • Must be self-directed and have attention to detail, with excellent written and verbal communication skills.  

Additional Information 
Our company  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.