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1 VAGA DE Designer EM São Bernardo do Campo / SP
Função/cargo da vaga:
Designer
Empresa:
Nome da empresa disponível para cadastrados.
Salário:
A combinar
Cidade/Estado:
São Bernardo do Campo / SP
Tipo de Vaga:
Home Office
Regime de contrato:
Efetivo/CLT
Descrição da vaga:
This position will help to maintain product compliance during the whole life-Cycle, for any category of products, for brazil territory, and to deliver core dossiers for latam, mainly for cosmetics and household products. Key responsibilities: report regularly the progress to the regional regulatory affairs department with meaningful metrics, particularly in terms of timelines, status of supportive data required from other functions and dossier preparation. Assist the regional & local regulatory affairs department in preparing submissions to competent authorities and notified bodies, ensuring timely approval of new products and life-Cycle submissions. Track outstanding documentation and notify the relevant regional regulatory affairs manager in a timely manner. Assist local submission of product dossiers, as well as ensure proper electronic archiving of all documents submitted to and received from competent authorities and notified bodies, to accurate data timely and keep update regulatory databases and tools for assigned products to comply. Update and maintain product registration and ingredients archives, databases and tracking tools. Upload and maintain technical files/dossier databases, as well as upload and maintain as required any documentation supporting the placing of the market of other categories of products e.G. Cosmetics, home care, consumer goods work closely with other regions to obtain the relevant documents and information for product dossiers. Collect appropriate documentation to support regulatory submissions in other countries when products are cross border sourced. Support local activities and processes such as checklist & third party notifications artwork approval: assist the regional regulatory affairs managers in the creation of ingredient lists for labeling purposes. Assist the regulatory affairs managers with artwork review and approval. Regulatory intelligence and product advocacy activities: understand current regulations, guidelines and standards relevant to ensure compliance to the applicable regulatory and corporate standards/requirements (medicinal products, medical devices, cosmetic products, biocides, detergents, consumer goods). Ensure that the content, organization and overall quality of all regulatory documents are adequate and compliant with local/regional regulatory requirements, commitments and agreements. Requirements: bachelor degree in chemistry, chemical pharmaceutical, engineer in chemistry or any related area. Experience in regulatory affairs, quality or product development in the pharmaceutical, medical devices or similar industries. Understanding of registration and regulatory requirements. Knowledge of industry practices, techniques and standards. Good written and verbal communicator with excellent interpersonal skills. Good planning and organizing skills. Attention to detail and sense of urgency. Ability to work in a dynamic environment and meet deadlines. Excellent digital literacy, which includes working with databases, software, ms office applications and google applications/tools. Fluency in spoken and written portuguese is mandatory. Advanced english level. Good skills in spanish language is a plus.
Cód. 10013003
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