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Consultant - Regulatory, New Product Development FA

Consultant - Regulatory, New Product Development FA
Flexible: any Elanco office in Switzerland, Belgium, France, Germany, Spain or UK
Flanders, Basel Stadt, Lower Saxony, Hesse, Madrid, Hauts-de-Seine, Hampshire
Belgium, Switzerland, Germany, Spain, France, United Kingdom
Europe; Middle East; Africa
Elanco Animal Health is a global animal health company that develops products and knowledge services to prevent and treat diseases in food animals and pets in more than 90 countries. Founded in 1954, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees.
Position Description:
This role contributes to the development of New Animal Feed Additive and/or Health Products for food animals by ensuring product development practices comply with global regulatory standards and guidelines. The Principal Consultant provides regulatory leadership in developing and implementing the global regulatory strategy for the development and approval of food animal projects in the EU.The individual in this role will work in partnership with product development teams and commercial teams to ensure robust data packages, such that regulatory submissions meet internal and external stakeholder expectations.In addition, the individual in this role will use their leadership skills to provide innovative solutions, create a positive and motivating work environment, which creates and delivers value to the Elanco portfolio.

Functions, Duties, Task:
Key Leadership Responsibilities
  • Provide leadership of the development and execution of regulatory strategy with focus on Europe
  • Effectively coordinate resources to execute regulatory submissions
  • Deliver high quality and approvable product submissions
  • Work effectively and flexibly within and across the Elanco research and development teams and European regulatory authorities to achieve overall Elanco deliverables
  • Meet with key influencers within relevant agencies including but not limited to the EU Commission, EFSA, EURL, EMA, and CVM
Key Technical Responsibilities
  • Coordinate the preparation of new animal feed additive and/or drug applications, renewals, protocols, submissions, supplemental and amended applications, general correspondence, and responses to European regulatory authorities.
  • Provides regulatory leadership in developing and implementing the European regulatory strategy for the global development of food animal feed additive registrations.
  • Provide technical expertise and sound scientific approach to product development and approval.
  • Critically participate in meetings that drive strategy and outcomes.
  • Work in partnership with product development teams to ensure robust data packages, submissions and communications meet internal and external stakeholder expectations.
  • Any other duties or projects as requested by the Line Manager commensurate with the grade and level of responsibility for this role, for which the employee has the necessary experience and/or training.
  • Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment and health, safety and environment (HSE) policies.
Master’s Degree or higher within the Life Sciences or equivalent experience

  • Demonstrated knowledge / experience in gaining successful registrations according to the EU Feed Additive registration processes (EC 1831/2003) and related regulations are required
  • Background in food animal sciences
  • Strong communication skills, both written and oral
  • Ability to make decisions when there is no clear right or wrong answer
  • Self-starter, takes initiative
  • Timeline driven
  • Attention to detail
  • Strong organization and an ability to multi-task; able to handle multiple projects at different phases of development at the same time
Fluent in English (written/verbal); desired proficiency in German; French

Location: role can be based in Switzerland, Belgium, France, Germany, Spain or UK
Expected travel requirements: up to 25%
Reports to: Advisor, Global Pharmaceuticals Regulatory New Product Development, FA