Regulatory Advisor, Global Regulatory Nutrional - Milano, Italia - Elanco

Elanco
Elanco
Azienda verificata
Milano, Italia

1 settimana fa

Piero Bianchi

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee
Descrizione

Education :

EQUIVALENTEXPERIENCE

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.

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 overarching goals are to ensure that high quality regulatory submissions are produced to meet the expectations of the EU regulatory authorities and our NH business customers, and that Elanco is compliant with US regulations

Functions, Duties, Tasks:


  • Provide leadership of development and execution of regulatory strategy for nutritional health innovation projects, focusing on EU regulatory strategy.
  • Effectively coordinate resources to execute regulatory submissions.
  • Work effectively and flexibly within and across Elanco R&D teams, external collaborators, and regulatory authorities to achieve overall Elanco R&D deliverables.
  • Be a source of technical regulatory knowledge (safety and efficacy and CMC) for development projects and when required geoexpansions.
  • Contribute to drafting and/or review of technical information and study protocols.
  • Actively participate in meetings that drive strategy and outcomes.
  • Proactively search for solutions to regulatory problems and deliver innovative technical solutions and create an innovative culture.
  • Manage project timelines, risk assessments, and facilitate deliver of the Elanco pipeline.
  • 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, antidiscrimination, harassment, and health, safety and environment (HSE) policies.

Core Competencies:


  • Strong knowledge of EU Feed additive requirement (EC Reg 1831/2003) and related regulations.
  • Scientific acumen to understand research requirements, assist in experimental design and interpretation of results.
  • Indepth understanding of safety and efficacy requirements food additives.
  • Strong communication skills, both written and oral
  • Selfmotivated, collaborative, innovative, and timeline driven.
  • Strong organization and an ability to multitask; able to handle multiple projects at different phases of development at the same time.

Education and Experience:


  • Masters Degree in Chemistry, Biochemistry, Animal Science, or equivalent scientific discipline, with three years of regulatory experience in EU registration of nutritional feed additives
  • PhD in Chemistry, Biochemistry, Animal Science, or equivalent scientific discipline, with one year of regulatory experience in EU registration of nutritional feed additives.
  • Fluent English is required
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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