Technician in Regulatory Issues

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.

Pharmaceutical regulation technicians 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.

• 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.

Regulated training and graduates

• Professional Training Course(s) in the field of Chemical Professional Families - Advanced Level: Pharmaceutical, biotechnological and Related Product Production
• Grau: Biologia
• Grau: Bioquímica
• Grau: Bioquímica i biologia molecular
• Grau: Biotecnologia
• Grau: Química
• Grau: Enginyeria química
• Grau: Biologia humana
• Grau: Farmàcia
• Grau: Medicina

Complementary training

Knowledge of registration and other pharmaceutical areas such as development, quality control and production is recommended.
Specific postgraduate education in the Pharmaceutical Industry or in Regulatory Affairs is recommended.
Knowledge of current regulations on Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
Knowledge of the ISO 9001:2000 standard and registration procedures.

Other specific skills

An advanced knowledge of spoken and written English is essential. Accustomed to working for objectives.
Strong knowledge of computer tools, especially MS-Office. Knowledge of regulatory mechanisms and information networks.
Knowledge of scientific and medical terminology, and excellent writing skills.
Willingness to travel, especially if a member of a multinational company or if registration applications are presented in European agencies or non-EU countries.

Pharmaceutical registration is the last step required before marketing a drug for a particular use, although obtaining it does not mean subsequent development. Therefore, to work in this position, professionals must have prior experience in the pharmaceutical, cosmetic or perfume industry or in clinical or pharmacological research. In addition, professionals must possess knowledge of drafting, compiling, publishing and managing regulatory or research documents.

In general, at least two years' experience as a technician or assistant in the Records Department of a pharmaceutical laboratory is required, although experience in quality control of medicines, in preparing quality audits or in preparing standardised operating procedures as well as relationships with public institutions and external clients are also highly regarded.

Analytical thought: Level 2

Orientation within reach: Level 3

Concern for order and quality: Level 2

Commitment to the organisation: Level 2

Initiative: Level 2

Communication: Level 2

Legal

People who are interested in the legal field like occupations related to legislation and the law. This field of interest includes advising people and institutions in legal matters, representing them in judicial processes and managing the documentation and procedures necessary for these processes. Carrying out these activities entails the study and knowledge of legal regulations and matters in their various scopes of application.

Logistics

The planning, organisation, control and carrying out of logistics and administrative tasks are the focus of people who work in the field of logistics. Activities in the field of logistics include the organisation and planning of supply, storage, production and distribution systems, taking inventories, controlling stock and estimating production, as well as the organisation and/or carrying out of the administrative tasks necessary for the implementation of these activities. Knowledge of organisation, control and management techniques is essential for carrying out these activities.

Study manager

Pharmaceutical product manager

Industrial property manager, specialised in biotechnology

Expert in food safety and quality

Drug development technician.

• Work hours

  Working days are usually full-time, with a continous or split schedule between 7-9 in the morning and 3-5 in the afternoon, Monday to Friday. In this occupation, there may be substantial time flexibility, due to meetings or conferences and the tasks of submitting and following up on registration applications filed with regulatory agencies. There may be part-time work in the case of staff from organisations under contract that work for a client company.

• Salary

  The average salary for this occupation is between 18,000 and 24,000 euros annual gross, depending on the candidate's experience and the type of industry. Nonetheless, it is usually higher in large multinational companies, where it is normally necessary to submit documentation in Europe or outside the EU. This beginning salary may increase based on the number of registrations made, since an incentive is paid per registration.

• Professional category

  Technician