Global Regulatory Lead, Animal Health Projects

Elanco Tiergesundheit AG; Hook; On-site; GBP 90,000 - 130,000; Full time

Benefits offered by this job

Travel 10-25%

Job summary

Elanco is seeking a Global Regulatory Project Lead to drive regulatory strategy and life cycle management for development projects on a global scale. You will collaborate with Global R&D, Sales, Marketing, and Supply Chain to deliver pre-approval and life cycle activities.

The role requires a Master’s degree or higher in veterinary or related field, 10+ years in animal health regulatory affairs, and proven leadership in regulatory submissions across geographies including EU and USA.

Qualifications

• Master’s degree or higher in veterinary medicine, biologic, infectious diseases, immunology, or a related field.
• Minimum of 10 years of experience in the animal health industry with direct Regulatory Affairs experience with biologics/large molecule products.
• Demonstrated regulatory leadership and dossier registration experience, with a strong understanding of global regulatory procedures and risk assessment fundamentals.

Responsibilities

• Lead regulatory strategy and development of technical documents for global development projects.
• Manage resources and provide technical leadership to ensure timely regulatory activities and compliance.
• Represent regulatory viewpoint on development teams and lead engagements with EU/USA regulatory agencies.

Skills

Regulatory leadership

Dossier registration

Global regulatory procedures

Stakeholder management

English fluency

Education

Master's degree or higher in veterinary medicine or related field

Job description

Elanco is seeking a Global Regulatory Project Lead to drive regulatory strategy and life cycle management for development projects on a global scale. You will collaborate with Global R&D, Sales, Marketing, and Supply Chain to deliver pre-approval and life cycle activities.

The role requires a Master’s degree or higher in veterinary or related field, 10+ years in animal health regulatory affairs, and proven leadership in regulatory submissions across geographies including EU and USA.