Regulatory Affairs Officer

il y a 2 semaines


Nantes, Loire-Atlantique, France NONSTOP CONSULTING Temps plein

Exciting Opportunity for a Regulatory Affairs Specialist


Our client is seeking a dedicated and knowledgeable Regulatory Affairs Specialist to join their team, reporting directly to the Scientific & Regulatory Director and functionally to the Regulatory Affairs Coordinator. This position will serve the Nantes site, playing a crucial role in ensuring compliance with regulatory requirements for a range of products.


Key Responsibilities:


- Regulatory Documentation Management:

- Oversee the creation, modification, and deletion of articles for regulatory purposes, including the development and updating of Safety Data Sheets (SDS) in collaboration with various departments.

- Submit necessary declarations to poison control centers and manage Biosidal Product Regulation (BPR) registrations.

- Assist in the creation and proofreading of product labels while ensuring all documentation is compliant with regulatory standards.

- Maintain and update the site database (ERP software) with respect to ADR, CLP, ICPE, TGAP, and customs nomenclature.


- BPR File Preparation:

- Collaborate with Christeyns Belgium to prepare and monitor BPR files, ensuring the provision of required documents in multiple languages, including labels, SDSs, and packaging documents.

- Update all relevant documents post-validation of BPR files.


- Communication & Support:

- Serve as a point of contact for French poison control centers, providing requested documents such as compositions, SDS, and labels.

- Advise and assist interdepartmental teams in Marketing, Sales, R&D, Quality, Production, and Purchasing regarding regulatory matters related to biocidal, detergent, and cosmetic products.

- Address customer requests for SDS, regulatory certificates, and assist in managing non-conformities.


- Regulatory Monitoring & Compliance:

- Conduct comprehensive regulatory monitoring on Biocide regulations, REACh for hazardous substances and preparations, CLP regulations, and more.

- Manage documentation resulting from regulatory monitoring and ensure updates in the computerized monitoring database.


- Project Management & Collaboration:

- Participate in cross-functional projects and may be involved in assessing the impact of product changes.

- Handle customer complaints and internal non-conformities within the scope of responsibility.

- Engage in activities in collaboration with colleagues from departments related to cosmetics, toxicology, or exports as necessary.


Essential Skills and Qualifications:


- Educational Background: 2-5 years of higher education in a scientific field (Chemistry, Pharmacy, Toxicology, etc.).

- Professional Experience: Proven experience in Regulatory Affairs with knowledge of CLP and Biocide regulations.

- Industry Knowledge: Familiarity with the biocides, cosmetics, and detergents markets.

- Technical Proficiency: Expertise in safety data sheet design tools (e.g., ExESS) and proficiency in office and IT management tools.

- Language Skills: Fluency in English, both written and spoken.


For more information, apply to this advert or send your CV to a.kanji@nonstopconsulting.com


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