Summary of duties
Take part in drawing up the Record file and applications for authorization to market veterinary medicines in the EU, in addition to managing variations.
Take part in drawing up the record file.
Plan the regulatory strategy for the application for marketing authorizations. Presentation of the record and follow up.
Plan and draw up responses to the lists of queries received from healthcare authorities.
Collaborate with the R+D team in the development of new products and advise on regulatory requirements. Collaborate in the design of studies and review of protocols and reports.
Review and advise on changes to products, evaluate their regulatory impact and manage the application for variations.
University degree in Pharmacy, Veterinary medicine, Biology, Biotechnology or similar.
Languages: Fluent English (C1).
Experience (years/area): +1 year in a similar position in the pharmaceutical industry.
- Regulatory legislation applicable to EU veterinary medicines.
- Pharmaceutical legislation and regulations.
Personal skills: Communicator, dynamic, proactive and team worker. Good written expression.
At Syva, we are always looking for dynamic talents who share our values and want to support the mission we have set ourselves, namely: "To provide solutions that make sense for our clients". If you also want to get involved with us and our clients, do not hesitate to consult our job offers.