A Regulatory Advisor for Global Nutritional Regulations - De Motte, IN, United States - Cascade Enterprises

James Miller

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James Miller

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Freelance
Description

Education:
Equivalent Experience


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. We believe that by making animals' lives better, we can make life better for everyone. Since 1954, we have been providing solutions to support veterinarians, farmers, and pet owners in our mission to enrich lives through food and companionship. Our promise to employees is to foster an inclusive culture where everyone can make a difference, encouraging ownership, growth, and well-being.

Job Purpose:


  • Responsible for leading the regulatory strategy (safety/efficacy and CMC) for the development and approval of animal nutritional health (NH) innovation products.
  • Act as an integral member of the NH R&D Team, and interface effectively with other functional areas including PVS&T, TS/MS, Manufacturing, Quality, and Supply Chain.
  • The main goals are to ensure highquality regulatory submissions that meet the expectations of EU regulatory authorities and our NH business customers, and to ensure Elanco's compliance with US regulations.

Functions, Duties, Tasks:


  • Lead the development and execution of regulatory strategy for nutritional health innovation projects, with a focus on EU regulations.
  • Coordinate resources effectively to complete regulatory submissions.
  • Collaborate with Elanco R&D teams, external collaborators, and regulatory authorities to achieve overall R&D goals.
  • Provide technical regulatory expertise (safety and efficacy and CMC

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