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Regulatory Affairs Manager

2 mesi fa

Roma, Lazio, Italia Elanco A tempo pieno
Job Title: Regulatory Affairs Manager

At Elanco, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.

About the Role

This role contributes to the regional registration activities for new and existing products by planning, coordinating, and delivering registration documentation to the regulatory agencies for assigned portfolio of products registered in two or more EEA countries (or the UK). The individual in this role is expected to work as a partner to support R&D, the EEA and UK affiliates and the line management to meet critical registration timelines in compliance with global regulatory standards and guidelines.

Key Responsibilities
  • Support submission preparation in execution of regulatory strategies for new and existing products to provide high quality submissions, reducing questions / hearings leading to optimal review times and speed to market.
  • Understand and evaluate a proposed product concept to provide the best possible product for the customer.
  • Collaborate with Marketing, R&D and any other relevant teams to develop and maintain product labelling text.
  • Proactively search for solutions and work effectively and flexibly within and across all Elanco teams and external collaborators to achieve overall Elanco deliverables.
  • Complete new and existing registrations to gain regulatory clearance for the import, manufacture, and/or use of new and existing science and products to enable business growth.
  • Proactively monitor, evaluate business impact, and communicate new and amended legislation and regulations.
  • Create a positive work environment that is aligned with company objectives.
  • Provide information to facilitate accurate and timely project and budget forecasts.
  • Manage project timeline and budget deliverables, as needed.
  • Support the preparation and execution of project meetings (pre and post approval) with regulatory authorities as well as other external partners/customers.
Requirements
  • Bachelor's degree in science related field or equivalent experience.
  • Demonstrated knowledge of EU regulatory processes – dossier preparation, submission and monitoring of post approval commitments.
  • Language Requirements: English. Any other language from EU region is an advantage.
What We Offer

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.