REGULATORY AFFAIRS SPECIALIST – ITALY

SAGEA SR Centro di Saggio s.r.l.; Alba; On-site; EUR 60,000 - 90,000; Full time

Job summary

SAGEA Group is seeking a Regulatory Affairs Specialist in Italy (Alba, Piedmont) to oversee registration of Plant Protection Products (PPPs) and Biological Control Agents (BCAs) under EU Regulation 1107/2009. You will plan the process, perform data gap analysis, conduct bibliographic research, write dossiers, and submit them to authorities.

The ideal candidate has 3+ years in PPP regulatory affairs, a PhD or MSc, fluent English, solid regulatory knowledge, and strong computer skills.

Qualifications

• 3+ years of regulatory affairs experience in PPPs.
• PhD or MSc degree required.
• Fluent spoken and written English.
• Good knowledge of regulatory requirements and regulations.
• Excellent computer skills.
• Strong sense of urgency with excellent prioritization skills.
• Strong problem solving and analytical background is a plus.

Responsibilities

• Plan the registration process for PPPs/BCAs.
• Analyse data gaps and identify missing data.
• Conduct bibliographic research for regulatory dossiers.
• Write registration dossiers.
• Submit dossiers to competent authorities.
• Perform registration follow-up and monitor progress.

Skills

Regulatory Affairs

Dossier Writing

English Proficiency

Regulatory Knowledge

Analytical Mindset

Education

PhD or MSc

Job description

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.