Regulatory Affairs Analyst, Operations

Detalles de la oferta

.No Relocation Assistance Offered 149305 - Del.Miguel Hidalgo, Mexico City, Mexico**This position will help to maintain product compliance during the whole life-cycle, for any category of products, for Mexico territory, as well as to deliver core dossier for LATAM, mainly for Cosmetics, Household Products and Medical Device.****Key Responsibilities**:- ** Report regularly the progress to Regional Regulatory Affairs Department with relevant KPIs, particularly in terms of timelines, status of supportive data required from other functions and dossier preparation.**- ** Assist the Regional Regulatory Affairs Department in preparing submissions to Competent Authorities and Notified Bodies, ensuring timely approval of new products and life-cycle submissions.**- ** Keep track of outstanding documentation and notify the relevant Regional Regulatory Affairs manager on a timely manner.**- ** Assist 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 in order to support regulatory submissions in other countries when products are cross border sourced.****Artwork Approval**:- ** Assist the Regional Regulatory Affairs managers in the creation of ingredient list for labeling purposes**- ** Assist the RA 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.**- ** Preferably 1-2 years of relevant 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


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

Analista Desarrollador

Ubicación: Pachuca, - Posición: Hibrida - Tareas: Analista técnico de tecnología Web - Experiência: Al menos 2 años como analista, con experiência previa com...


Isita - Hidalgo

Publicado 11 days ago

Analista De Prevencion De Fraudes

The Service Associate position is an entry-level position responsible for executing customer service activities, while ensuring adherence to Citi's policies ...


Citi - Hidalgo

Publicado 11 days ago

Analista De Social Media Para Cesvin Inmobiliaria

**CESVIN INMOBILIARIA BUSCA ANALISTA DE SOCIAL MEDIA** Educación: Lic. Mercadotecnia o carrera afín. **Experiência requerida** - ****Uso de plataformas - M...


Arrendadora Cesvin - Hidalgo

Publicado 11 days ago

Analista De Estudios Socioeconomicos

No se les dan prestaciones es a modo de freelance solo cuando hay estudios en la zona interesados postularse por este medio o mandar un whatsapp al 556


Psiconet Consulting Mexico Sc - Hidalgo

Publicado 10 days ago

Built at: 2024-11-21T17:24:03.915Z