Play a key role in shaping the global regulatory strategy for a broad portfolio of veterinary products
Act as a central interface between internal teams and external partners
Drive the setup and continuous development of an international outsourcing program
Ensure the highest quality and compliance standards
Collaborate with colleagues across the globe
Take on a pivotal role in a dynamic and highly interconnected environment
Provide key support in establishing the outsourcing program
Conduct satisfaction surveys and evaluate the quality of out‑licensed activities
Oversee related maintenance activities on a global scale as well as dossiers for geographic expansion
Assess regulatory initiatives and legislative changes for relevance to the out‑licensed product portfolio
Follow up on global vendor management activities in coordination with RA Senior Managers and the Head of the RA Service Center
Review invoices for content accuracy and support budget planning
Manage external partners within the outsourcing program
Serve as the interface for all process‑related and regulatory issues regarding the out‑licensed product portfolio
Initiate or support infrastructure projects as assigned
Requirements
Licensed pharmacist, or alternatively a veterinarian or biologist with a master’s degree
Several years of experience in international regulatory affairs with a solid understanding of international regulatory processes and procedures
Expertise in regulatory requirements for the approval of veterinary medicinal products in the EU; familiarity with European approval procedures (Centralised Procedure, Decentralised Procedure, Mutual Recognition Procedure) and non‑EU procedures
Excellent communication skills and a cross‑cultural mindset (especially for interactions with US, France and local OPUs); good understanding of processes and stakeholders within BIAH
Experience in vendor management and oversight
Diplomatic skills for mediation and negotiations
Strategic and solution‑oriented mindset
Willingness to travel occasionally
Benefits
Comprehensive benefits and wellbeing package
Applications from people with severe disabilities are warmly welcomed