Senior Regulatory Affairs Manager, EU Procedures (Hybrid)

Elanco; Antwerpen; Hybrid; EUR 80,000 - 110,000; Full time

Benefits offered by this job

Hybrid work model

Travel opportunities

Location flexibility

Job summary

Elanco in Antwerp, Belgium, is seeking a (Senior) Regulatory Affairs Manager, EU Procedures, to support regional registration activities for animal health products across multiple EU countries. You will coordinate regulatory submissions, labeling, and post‑approval commitments with affiliates, global teams and authorities.

You will manage timelines using Vault RIM, liaise with cross‑functional teams, monitor regulatory changes, and contribute to process improvements.

Qualifications

• Bachelor’s or Master’s degree in veterinary medicine, biologic, infectious diseases, immunology, or related field.
• 2+ years of experience in regulatory affairs.
• Fluent English.
• Ability to prepare complete, high-quality technical submission packages.

Responsibilities

• Coordinate the planning, preparation, publication and delivery of high-quality technical submission packages for EU/UK procedures.
• Manage regulatory submission timelines and tracking for innovation and established products using Vault RIM.
• Partner with European affiliates, Marketing, R&D and other functions to meet national requirements and maintain product labeling and compliance.
• Act as a point of contact for regulatory authorities and support authority meetings, questions and responses.
• Monitor changes in legislation and regulatory guidance, assess impact and contribute to process improvements and forecasting.

Skills

Regulatory affairs knowledge

Submission coordination

English proficiency

Regulatory submissions (EU/UK)

Education

Bachelor’s or Master’s degree in veterinary medicine/biologic/immunology or related field

Tools

Vault RIM

Job description

Elanco in Antwerp, Belgium, is seeking a (Senior) Regulatory Affairs Manager, EU Procedures, to support regional registration activities for animal health products across multiple EU countries. You will coordinate regulatory submissions, labeling, and post‑approval commitments with affiliates, global teams and authorities.

You will manage timelines using Vault RIM, liaise with cross‑functional teams, monitor regulatory changes, and contribute to process improvements.