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LABELLING REGULATORY AFFAIRS OFFICER (H/F). Bélgica

Vacantes en Bélgica de Farmacéuticos

Clasificación del trabajo: Profesionales científicos e intelectuales : Profesionales de la salud : Otros profesionales de la salud : Farmacéuticos.

Intellectuele, wetenschappelijke en artistieke beroepen : Specialisten op het gebied van de gezondheidszorg : Andere specialisten op het gebied van de gezondheidszorg : Apothekers

Descripción de la oferta de trabajo:

ProductLife Group is the European industry-leading specialist service provider for the Life Sciences industry, focused on delivering high quality professional services in the areas of Regulatory, Safety, Quality, Process alignment and Medical services. All ProductLife Group's services are targeting support for comprehensive compliance and safety throughout the product life cycle, therefore enabling continuity and productivity of product development and subsequent processes.

As a result of the deployment of a new project we are now seeking a Labelling Regulatory Affairs Officer.

Primary Responsibilities

Guarantee the management, writing and updates of labeling documents (for local products documents and local language documents, control the artworks) and regulatory files according to the objectives and regulatory requirements. - Preparation, constitution, and control of the regulatory parts of the registration dossiers in collaboration with the regulatory teams. - Communication, organization and prioritization of regulatory documents. - Implement with the Regulatory Affairs teams the strategies and the planning to update the documents. - Ensure the analysis and development of appropriate content for the documentation. - Control the development of documentation Labelling, tools and processes to support submissions to the authorities. - Provide regulatory support to customers and associates.

Candidate profile

Education: Bachelor or higher graduate degree in a science related field, or equivalent experi-ence.

Experience: Experience should include a proven understanding of the regulatory process and experience in leading a project to successful completion.

Key skills

Good regulatory knowledge. - Excellent organizational and interpersonal skills (written and verbal fluency) - Process orientated with good attention to details. - Computer literate and the ability to learn appropriate software. - Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel - Analytical evaluation skills.

Core competencies

Ability to work well within a team - Process orientated with good attention to detail - Effective oral and written communication skills - To comply with the company's policies and procedures to meet statutory, quality and busi-ness requirements within the overall strategy and objectives - English(spoken and written) and French/Dutch(will be an advantage) for daily contacts with local and international.

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País del trabajo: Bélgica.

Número de puestos: 1.

Tipo de puesto: Contratación directa.

Nivel educativo: Educación primaria.

Tipo de contrato: Jornada completa.

Empleador: PRODUCT LIFE.

Idiomas: inglés (Intermedio).

Instrucciones para solicitar:

envoyer une lettre de motivation et un C.V. via e-mail productlife-group.com" rel="nofollow">aambrosproductlife-group.com

Identificador de la vacante:902376.

Ver las 78 ofertas de trabajo de Profesionales científicos e intelectuales : Profesionales de la salud : Otros profesionales de la salud : Farmacéuticos ofertadas.

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