Job Description
Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.
Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.
For our innovative research location in Schwabenheim (near Mainz), we are looking for a full-time and initially limited to 2 years Senior Specialist Regulatory Affairs (m/w/d) – CMC – Site Transfers (#ILC/ Project pink) as soon as possible.
The focus of this position is on the processing of variations for multiple products within the scope of a defined project in close coordination with colleagues within the global regulatory affairs team and the responsible finished product
manufacturing facilities.

TRAVEL REQUIREMENTS:

25%

REQUIRED SKILLS:

Adaptability, Adaptability, Communication, Detail-Oriented, Employee Training Programs, Executive Communications, Immunochemistry, Maintenance Management, Management Process, Microbiology, Organizational Communications, Pharmaceutical Management, Pharmaceutical Regulatory Affairs, Phytochemistry, Product Approvals, Professional Etiquette, Project Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory CMC, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Audits, Regulatory Experience, Regulatory Submissions {+ 4 more}

• Global Regulatory representative within the project
• Evaluation of requirements for registered markets and necessary variations and/or marketing authorization transfers
• Preparation and submission of identified variations and/or marketing authorization transfers
• Maintenance and updating of regulatory CMC dossiers
• (Co-)development of regulatory concepts and preparation of documentation for change notifications, taking into account current regulatory quality standards
• Timely response to inquiries from countries and authorities
• Technical support of other functions in regulatory issues
• Collection and maintenance of regulatory information, taking into account the associated processes, as well as maintenance of the relevant systems and databases
• Act as Regulatory Information Specialist in Veeva Vault