Head of Affiliate Regulatory and Pharmacovigilance CEERTMEA

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.

At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment.

We believe that diversity is the driving force behind innovation, creativity, and overall business success.

Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your Role: Head of Affiliate Regulatory & Pharmacovigilance, CEERTMEA

As Head of Affiliate Regulatory & Pharmacovigilance, CEERTMEA, you will lead all regulatory affairs and pharmacovigilance activities for Elanco's CEERTMEA operations, ensuring compliance and strategic product lifecycle management.

In this role, you’ll be responsible for developing and executing robust regulatory strategies for both existing and new products, and for leading pharmacovigilance processes to ensure product safety and efficacy.

Your Responsibilities:


* Regulatory Strategy & Execution: Develop, implement, and manage comprehensive CEERTMEA regulatory strategies for the lifecycle management of registered products (e.g., variations, renewals, line extensions) and new product registrations in non-EU countries.

This includes acting as the primary point of contact with regulatory agencies, providing expert regulatory intelligence to cross-functional teams, proactively monitoring legislation changes, and leading the preparation and submission of high-quality technical packages.


* Pharmacovigilance (PV) Oversight: Ensure full PV compliance in CEERTMEA with local, global, and internal requirements, including audit and inspection readiness.

This involves line management of the CEERTMEA PV Team, building relationships with external stakeholders, collaborating with Elanco GPV, ensuring appropriate training, and supporting new product launches.


* Leadership & Team Management: Lead, mentor, and develop a high-performing team of regulatory and pharmacovigilance professionals, fostering a culture of accountability, continuous improvement, and strong ethical conduct.

This also includes managing departmental resources and representing CEERTMEA's regulatory and PV interests in regional and global forums.


* Cross-functional Collaboration & Business Partnership: Serve as a key strategic partner to CEERTMEA Commercial, Marketing, Legal, and Quality teams, integrating regulatory and PV perspectives into business planning and decision-making.

This involves providing critical input into commercial sales activities and facilitat...