Local Pharmacovigilance Manager & Regulatory Manager

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:

In this combined Pharmacovigilance (PV) and Regulatory Affairs (RA) role, you will act as the local representative of the Elanco Pharmacovigilance organization in France while ensuring the regulatory compliance of our product portfolio.

As Local Pharmacovigilance Manager (LPVM), you will lead local pharmacovigilance activities, maintain the local PV system and ensure compliance with French regulatory and Elanco requirements.

As Regulatory Manager (RAM), you will manage regulatory activities for assigned products, maintain existing Marketing Authorizations and contribute to new registrations in France.

Your Responsibilities:



* Act as the key local point of contact and provide leadership for all Pharmacovigilance matters within the French affiliate.


* Maintain and oversee the local pharmacovigilance system, ensuring compliant management and reporting of Adverse Events (AEs) and Product Complaints (PCs).


* Manage PV-related communication with Regulatory Authorities and ensure appropriate training, documentation and ongoing compliance with local and Elanco requirements.


* Coordinate PV audits and inspections, maintain inspection readiness and work closely with the EU QPPV, Global PV and Quality teams on product safety and risk management activities.


* Manage relationships and interactions with relevant Regulatory Authorities and provide regulatory guidance to the business.


* Plan and coordinate regulatory activities for assigned products, including new registrations and maintenance of existing Marketing Authorizations (MAs).


* Ensure ongoing regulatory compliance through timely submission of variations, change controls and other required regulatory documentation, including compliance of product information and promotional materials.


* Partner with local, European and global cross-functional teams and proactively identify opportunities to improve product safety, regulatory compliance and operational efficiency.

What You Need to Succeed (minimum qualifications):



* University-level education in a pharmaceutical or life-science discipline, such as veterina...