EU Regulatory Affairs Lead – Procedures & Submissions

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

Benefits offered by this job

None

Job summary

Elanco is seeking a (Senior) Regulatory Affairs Manager, EU Procedures, to support regional registration activities for existing animal health products across EU and the United Kingdom.

You will coordinate regulatory submissions, product labelling activities and post-approval commitments while partnering with affiliates, global teams and regulatory authorities to maintain marketing authorisations and support continued product supply.

Qualifications

• Bachelor’s or Master’s degree in veterinary medicine, biologic, infectious diseases, immunology, or a 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.

Responsibilities

• Coordinate the 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 for innovation and established products using Vault RIM, ensuring critical milestones are delivered on time.
• Partner with European affiliates, Marketing, Research and Development and other relevant functions to complete national requirements, maintain product labelling and support product compliance.
• Act as a point of contact for regulatory authorities and support the preparation and execution of authority meetings, questions and responses, as well as post-approval commitments.
• Monitor changes in legislation and regulatory guidance, assess their business impact and contribute to process improvements, regulatory advocacy and effective project and budget forecasting.

Skills

Fluent English

Interpersonal skills

Communication skills

Education

Bachelor’s or Master’s degree in veterinary medicine/biologic/infectious diseases/immunology

Job description

Elanco is seeking a (Senior) Regulatory Affairs Manager, EU Procedures, to support regional registration activities for existing animal health products across EU and the United Kingdom.

You will coordinate regulatory submissions, product labelling activities and post-approval commitments while partnering with affiliates, global teams and regulatory authorities to maintain marketing authorisations and support continued product supply.