Senior Specialist Regulatory Affairs (m/w/d) – CMC – Site Transfers

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.

Main responsibilities:

• 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

Your profile:

• Master's degree in Pharmacist, Chemist, Food Chemist or Biologist

• Ideally, you have professional experience in comparable positions in the pharmaceutical industry. However, applications from university graduates are also welcome.

• Consistent, flexible, team-oriented and familiar with MS Office

• Careful and responsible way of working

• You combine organizational skills with strong communication skills in an international environment

• Very good verbal and written language (English essential, German & Italian desirable)

Our offer:

• Flexible working hours (37.5 hours/week) and an attractive company pension scheme

• Competitive salary package: 13 monthly salaries + holiday pay + target bonus

• 30 days holiday entitlement (depending on location)

• Hybrid or remote working model (depending on location)

• Internal training and promotion opportunities

• International co-operations

• Training on the job

• Contributing your own ideas to the process design

• Insights into the development of veterinary medicinal products

• Corporate benefits and free (electric) car parking

• Good company canteen and a company health management program

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach