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Regulations

In compliance with Organic Law 15/1999, of 13 December, under the Personal Data Protection Act, we inform you that data collected will form part of an automated file, under the ownership of BARCELONA ACTIVE SPM S.A., with registered office at 162-164 Calle Llacuna, Barcelona, with the aim of managing enrollments and of informing of the company's activities and services within its field of action. You will be able to exercise access rights, rectification, cancel cancellation and/or opposition via written communication to the Legal Services of BARCELONA ACTIVE SPM S.A. at the aforementioned address.

 
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Technician in Regulatory Issues

Description

The chemical industry of health is one of the sectors with the greatest involvement of public authorities. This affects the various stages of the production process and marketing, mainly the administrative approval of drugs through compulsory registration, pricing, and the regulation and control of procedures for R&D and manufacturing. Experts in registrations work at large and medium-size companies related to the manufacturing of pharmaceuticals, cosmetics or perfumery. At SMEs, their work may be performed directly by the person in charge of regulatory affairs, the tecnical director or the quality manager, or it may be done by a company specalising in the legal processing of registrations. This professional is in charge of preparing documentation necessary for the submission and approval of new products, thus taking responsibility for preparing registration dossiers, for delivering them to relevant regulatory agencies (the European Medicine Evaluation Agency [EMEA] in Europe and the Spanish Agency of Medicines in Spain), and for monitoring the evaluation process. In addition, this professional keeps approvals up-to-date by regularly providing evidence or documents required by health authorities, in collaboration with other departments in the company.

Tasks

  • Assess projects and advise General and Sales Management on their feasibility.
    Assist in the search for and contracting of new projects, together with the Sales Department.
    Report on regulatory needs according to product categories and countries, and propose appropriate registration strategy to superiors.
  • Oversee, review and prepare all documentation to be delivered to Health Authorities.
    Conduct studies on registration methods to achieve regulation.
    Develop standard operating procedures for registrations.
    Regularly report on the progress of registration projects, providing advice on technical issues.
    Plan timing for each registration, in conjuntion with the Management.
    Assess internal and/or external tasks that should be performed in order to optimise the timing of the various stages of registration.
    Prepare, review and update product specifications and adapt them to the legislation of the countries where the product is sought to be registered.
  • Request approval from regulatory agencies for medicines and products that have completed the various stages of pre-clinical and clinical research.
    Represent the company before national and regional public health institutions and in export projects.
    Monitor the progress of registrations once they have been submitted to Health Authorities and handle requests made by these organisations, acting as a liaison with the company.
    Adopt technical measures necessary to resolve problems arising during the course of duties.
    Ensure that national and international registrations are renewed and maintained.
    Maintain a close relationship with regulatory authorities or other groups related to the authorization of medicines or their marketing in Spain, the European Union or the world.


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Centre per al desenvolupament professional Porta22
Convent de Sant Agustí
Ca n'Andalet

Barcelona Treball (Porta22)
+34 934 019 899
bcn.cat/treball

Barcelona Activa Headquarters
Llacuna, 162-164
08018 Barcelona
+34 934 019 777
bcn.cat/barcelonactiva

Generalitat de Catalunya
Unió Europea FEDER
Unió Europea FSE