EU Regulatory Affairs Lead — Submissions & Compliance

Elanco; Reading; Hybrid; GBP 60,000 - 90,000; Full time

Job summary

Elanco, a global leader in animal health, is seeking a (Senior) Regulatory Affairs Manager, EU Procedures. You will support regional registration activities for existing products across EU and United Kingdom, coordinating submissions, labelling, and post-approval commitments.

You will partner with affiliates, Marketing, R&D and regulatory authorities to maintain marketing authorisations, manage timelines using Vault RIM, and ensure high-quality technical packages.

Qualifications

• Bachelor’s or Master’s degree in veterinary medicine or related field.
• 2+ years of experience in regulatory affairs.
• Fluent English.
• Ability to prepare high-quality technical submission packages.
• Experience coordinating submission components (national requirements, translations, fee payments).

Responsibilities

• Coordinate planning, preparation, publication and delivery of high-quality technical submission packages for European Union and United Kingdom regulatory procedures.
• Manage regulatory submission timelines, tracking and prioritisation using Vault RIM to deliver milestones.
• Partner with European affiliates, Marketing, R&D and other functions to complete national requirements and support labeling.
• Act as a point of contact for regulatory authorities and support authority meetings, questions and post-approval commitments.
• Monitor changes in legislation and regulatory guidance and contribute to process improvements and budgeting.

Skills

Fluent English

Interpersonal skills

Communication skills

Education

Vet/biol sciences degree

Job description

Elanco, a global leader in animal health, is seeking a (Senior) Regulatory Affairs Manager, EU Procedures. You will support regional registration activities for existing products across EU and United Kingdom, coordinating submissions, labelling, and post-approval commitments.

You will partner with affiliates, Marketing, R&D and regulatory authorities to maintain marketing authorisations, manage timelines using Vault RIM, and ensure high-quality technical packages.