We are recruiting a Records Technician for the R+D Pharmacological Department

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.

Specific responsibilities

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.

Requirements

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.

Specific knowledge:

• Regulatory legislation applicable to EU veterinary medicines.
• Pharmaceutical legislation and regulations.

Personal skills: Communicator, dynamic, proactive and team worker. Good written expression.