Job Title: Senior Regulatory Specialist- Licensing
Our client is a one of the biggest players in the biomedical industry active in human and animal health products. One of their main focus points are to invest in innovation and to improve the lives of the people around the world.
In this role you will be part of the biologicals team within the Global Regulatory Affairs department focused on the content of the regulatory compliance for veterinary products. Your main tasks will be to take full control of the licensing of new products as well as to assist with the regulatory tasks associated with the products on the market.
- Act as a point of contact between the department and the authorities
- Be responsible for the communication with authorities and provide information related to licensing regulations
- Take charge in the translations processes for products by keeping contact with CORAs and EMA
- Evaluate marketing approvals and transfers the data into a system
- Apply and support licensing methods, be a couch for inexperienced colleagues
- Support licensing and create strategy
- Take part in meetings and projects related to licensing procedures
- Minimum a Bachelor in Chemistry, Biology, Veterinary or related
- Minimum 3 years’ experience as Regulatory Affairs in biology
- Outstanding communication, resolution and analytical skills
- Excellent English, Dutch is a plus
- Ability to work information systems
Are you interested in this job or do you know someone who will be interested, please contact Plamena Koleva and apply via the vacancy.