REGULATORY AFFAIRS SPECIALIST – ITALY

SAGEA Group; Torre Bormida; In loco; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

SAGEA Group is seeking a Regulatory Affairs Specialist in Alba, Piedmont, Italy, to lead registration activities for Plant Protection Products (PPPs) and Biological Control Agents (BCAs) under EU Regulation 1107/2009. The role requires strong regulatory knowledge and hands-on dossier writing experience.

You will plan the registration process, perform data gap analyses, conduct bibliographic research, and prepare submissions to authorities, ensuring timely registration follow-up and compliance.

Competenze

• 3+ years of experience in Regulatory Affairs of PPPs.
• PhD or Master of Science degree.
• Fluent spoken and written English.
• Good knowledge of regulatory requirements and regulations.
• Excellent computer skills.
• Strong sense of urgency with prioritization.
• Strong problem solving and analytical background.

Mansioni

• Planning of the registration process
• Analysis of data gaps
• Bibliographic research
• Writing of the dossiers for the registration process
• Submission of the dossiers to competent authorities
• Registration follow-up

Conoscenze

Regulatory affairs

PPPs knowledge

Dossier writing

Data analysis

Formazione

PhD or MSc

Strumenti

MS Office

Descrizione del lavoro

Role purpose

SAGEA Group is hiring a Regulatory Affairs Specialist in Italy (Alba/Piedmont) for registration of Plant Protection Products (PPPs) and Biological Control Agents (BCAs) according to the EU Regulation 1107/2009.

The Specialist Will Have To Perform The Following Activities

• Planning of the registration process
• Analysis of pre-existing data an identification of lacking data (Data Gap Analysis)
• Bibliographic research
• Writing of the dossiers for the registration process
• Submission of the dossiers to competent authorities
• Registration follow- up

We are looking for the following knowledge, experiences and capabilities:

• 3 or more years of experience in Regulatory Affairs of PPPs
• PhD or Master of Science degree
• Fluent spoken and written English
• Good knowledge of regulatory requirements and regulations
• Excellent computer skills
• Strong sense of urgency combined with excellent prioritization skills
• Strong problem solving skills and analytical background will be an added value

We offer rewarding and challenging careers where you can make a difference in a dynamic market, with exciting opportunities for personal development and achievement.