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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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Regulatory Affairs Specialist

Description

Developing a drug or product that has an effect on a living organism is a highly complex process that must conclude by submitting the registration to regulatory agencies such as the AEMPS (Spanish Agency of Medicines and Medical Devices), the EMA (European Medicines Agency) and the FDA (US Food & Drug Administration) . Submitting the registration is the culmination of work that encompasses everything from the initial idea of what and how the new drug or product should be to submission of the registration and subsequent entry on the market. These professionals are necessary in different kinds of industries: cosmetics, pharmaceuticals, food, etc. The person in charge of regulatory affairs is responsible for ensuring that the entire development of a new product that has an effect on a living organism (from protocols in early preclinical stages and in clinical trials to submission of documentation to the corresponding regulatory agencies) complies with current regulations on efficacy and safety, in accordance with the type of product or pathology, in the case of drug development.

Tasks

  • Establish the strategy to adapt the company's projects to current regulations.
  • Work in collaboration with quality and records departments, as well as with scientific R&D teams, to ensure that experimental studies necessary to comply with international regulations are designed and conducted and to ensure that generated documentation meets standards required to guarantee product efficacy and safety.
  • Remain in permanent contact with public institutions, regulatory agencies and notifying organisations to request registration approvals, defend the company's projects and keep abreast of regulatory changes that may affect the development of projects.
  • Keep approvals up-to-date, regulary presenting required tests or documents.
  • Hire international experts and consulting firms specialising in specific markets and product types to increase the likelihood that products will be approved with the minimum time and cost for the company.
  • Coordinate official audit inspections that certify that regulatory standards are being followed and that control the quality of the company's laboratories, together with the person responsible for quality.
  • Attend courses and conferences to keep abreast of current regulations in order to plan for implementation in the company.
  • Depending on the structure of the company, may be part of the records department or be a separate department within the organisation.

Quick access and copyright:

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