EU/GB Regulatory Affairs - Marcq-en-Barœul, France - lesaffre

Description

Job description

As part of a new position, we are looking for an EU/GB Regulatory Affairs & Scientific Specialist for Phileo.

Within Phileo's "Quality Products and Compliance" department, in an international environment and in a context of growth, you interpret and define the regulatory requirements applicable to Phileo products in the EU and Great Britain, and you implement the necessary actions to ensure their compliance. You coordinate authorization and renewal requests as an additive for animal feed with competent authorities (EFSA, FSA), ensuring the preparation, submission, and follow-up of these requests. You also coordinate responses to questions from these authorities regarding ongoing authorization and renewal requests ("Risk Assessments", etc.).

You are also responsible for monitoring, applying and anticipating regulations applicable to Phileo and its clients in the relevant regions.

Reporting to the Global Regulatory Affairs & Market Access Team Leader, your main missions are as follows:

Regulatory monitoring and strategy:

– Ensure regulatory monitoring and anticipate regulatory changes related to Phileo's activity;
– Identify regulatory requirements applicable to new products or improvements to existing products;
– Contribute to the definition of regulatory strategy in relevant regions, in collaboration with the Global Regulatory Affairs & Market Access Team Leader and Phileo teams;
– Contribute actively to innovation and development projects related to animal nutrition and health.

Management of authorization dossiers for "Additives" in the EU/GB:

– Gather the necessary information to support authorization and renewal requests for animal feed additives in the EU and GB;
– Define, implement and monitor the scientific testing required in accordance with EFSA/FSA requirements, in collaboration with the relevant departments;
– Manage statistical and scientific analysis of data from test results;
– Prepare authorization and renewal dossiers and coordinate their submission to competent authorities in the EU and GB, in collaboration with the regulatory assistant;
– Follow-up dossier processing, responding to requests from authorities or clients;
– Ensure compliance with budget and deadlines;
– Draft and validate the content of Phileo product labels in the relevant regions.

As part of your duties, you are the privileged contact for several Phileo and Lesaffre group services: Downstream Development, Quality, Customer Service, Marketing, Sales departments, R&D, production sites, Group Regulatory Affairs department, etc.

You also liaise with consultants and other external service providers. You will work closely with the regulatory assistant.

Qualifications

With a scientific background and excellent technical expertise (ideally at the PhD level in the field of animal nutrition and health), you have at least 5 to 10 years of experience in regulatory affairs in the animal nutrition and/or health sector, with experience in authorization and renewal requests as an additive for animal feed in the EU. You have a mastery of statistical data processing techniques.

You act as a "facilitator" within the company and enjoy working in project mode. You have good communication skills, both oral and written. Your rigor, attention to detail and results-oriented approach, as well as your team spirit, enable you to effectively move your own projects and those of the team forward. Your client-oriented approach will make you a key collaborator in the team.

Fluent English (written and spoken) is essential.

This position is based in Lille, France, and may require occasional travel in France and abroad. Partial remote work is possible (up to 2 days per week).