Regulatory Affairs Specialist

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.

• 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.

Regulated training and graduates

• Grau: Farmàcia
• Grau: Biologia
• Grau: Biotecnologia
• Grau: Química
• Grau: Bioquímica
• Grau: Medicina
• Grau: Ciències biomèdiques

Complementary training

Seminars organised by the Regulatory Affairs Professionals Society.
Companies often train their staff themselves.

Initiative: Level 3

Communication: Level 3

Flexibility and change management: Level 2

Customer orientation: Level 2

Planning and organisation: Level 2

Team work and cooperation: 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.

Industrial property manager, specialised in biotechnology

Medical writer

Study manager

Pharmaceutical product manager

Crystallography technician

• Work hours

  The work day can be part-time or full-time.

• Professional category

  Technician