Senior Specialist Regulatory Affairs (mwd) â CMC â 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 worlds 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 Schwabenheim (near Mainz) we are looking for a full-time and initially limited to 4 years Senior Specialist Regulatory Affairs (m/w/d) CMC Site Transfers (#ILC) as soon as possible.

The focus of this position is on the processing of site transfers for multiple products 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 assigned product transfer projects

• Evaluation of requirements for registered markets

• Preparation and submission of product site 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

Your profile:

• Masters degree as 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 German)

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 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 anothers thinking and approach problems collectively. We are an equal opportunity employer committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

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