EU Regulatory Affairs Manager — Veterinary Medicines (Hybrid)

Elanco; Utrecht; Híbrido; EUR 90 000 - 120 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work model

Travel 10%

Resumo da oferta

Elanco, a global leader in animal health, seeks a (Senior) Regulatory Affairs Manager, EU Procedures, to support regional registration activities for veterinary products across EU/UK. Based in the Netherlands, you will coordinate regulatory submissions, labeling updates and post-approval commitments with affiliates and authorities.

You will collaborate with Regulatory, Marketing and R&D, manage timelines with Vault RIM, monitor legislation, and contribute to process improvements and budgeting.

Qualificações

• Bachelor’s or Master’s degree in veterinary medicine, biology, infectious diseases, immunology, or related field.
• 2+ years of experience in regulatory affairs.
• Fluent English.
• Ability to prepare and deliver complete, high-quality technical submission packages to competent authorities.
• Experience coordinating submission components such as national requirements, translations, fee payments and dossier publication.

Responsabilidades

• Coordinate planning, preparation, publication and delivery of high-quality submission packages for EU and UK regulatory procedures.
• Manage regulatory submission timelines and prioritisation using Vault RIM to meet milestones.
• Partner with European affiliates, Marketing, R&D and other functions to meet national requirements and maintain labeling.
• Act as contact for regulatory authorities and support meetings, questions, responses and post-approval commitments.
• Monitor legislation changes, assess impact and contribute to process improvements and budgeting.

Conhecimentos

Fluent English

Strong interpersonal skills

Regulatory submissions planning

Formação académica

Bachelor’s or Master’s in veterinary medicine, biology, infectious diseases, immunology, or related field

Ferramentas

Vault RIM

Descrição da oferta de emprego

Elanco, a global leader in animal health, seeks a (Senior) Regulatory Affairs Manager, EU Procedures, to support regional registration activities for veterinary products across EU/UK. Based in the Netherlands, you will coordinate regulatory submissions, labeling updates and post-approval commitments with affiliates and authorities.

You will collaborate with Regulatory, Marketing and R&D, manage timelines with Vault RIM, monitor legislation, and contribute to process improvements and budgeting.