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Regulatory Affairs Officer
Il y a 2 mois
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
