(Senior) Manager RA(m/w/x)

Beschreibung

You will drive the global lifecycle of veterinary medicines by defining CMC strategies and managing regulatory dossiers while acting as a key liaison between the organization and international authorities.

Anforderungen

• •Master’s or university degree in Life Sciences
• •Initial experience in Regulatory Affairs or development
• •Understanding of pharmaceutical veterinary regulatory requirements
• •Excellent communication, negotiation and interpersonal skills
• •Excellent command of English
• •Experience in Regulatory Affairs or comparable roles
• •Knowledge of veterinary medicinal product requirements
• •Awareness of industry trends and competitors
• •High initiative and strong organizational skills

Aufgaben

• •Define CMC regulatory requirements for assigned initiatives
• •Represent the RA CMC function in cross-functional teams
• •Serve as the central contact for technical and regulatory stakeholders
• •Oversee geographical expansion activities for veterinary products
• •Manage regulatory activities from submission to procedure completion
• •Liaise with the EMA and national competent authorities
• •Prepare and review quality-related documentation for dossiers
• •Support regional and local teams with product registrations
• •Develop and implement global regulatory strategies
• •Update and maintain regulatory tools and databases
• •Lead or support internal infrastructure projects
• •Engage proactively with regulatory authorities and external partners

Benefits