The development professions focus on the analytical and galenic development of a drug and on regulatory affairs. Therefore, scientific expertise is required for these multiple professions. Here are a few of them.
The analytical development technician participates in projects for the development of new pharmaceutical products and industrial transfers. He also helps to implement analytical methods and control strategies in compliance with GMP (Good Manufacturing Practices) rules and regulations in place. This job requires creativity in order to propose investigations and solutions to the analytical problems encountered.
The galenic development manager is responsible for the galenic development plan in terms of strategy, technique and timing, in accordance with the regulations in place. He is therefore required to plan, organise and follow up his team’s activities through the creation of performance indicators. Moreover, this job enables him to be in close contact with clients during the project period.
The Regulatory Affairs Manager supervises and coordinates a team of business officers. In this way, he manages all the department’s activities while keeping a watchful eye on standards and regulations. In compliance with the various pharmacopoeias, legislations and guidelines, he is responsible for activities related to the registration and regulatory maintenance of products: marketing authorisation files (drafting pharmaceutical modules, answering questions from Health Authorities, etc.) and provides expertise on regulatory aspects at the various stages of product development.
The development project manager handles several client projects with direct links between the analytical and galenic development teams. Therefore, he can be called upon to provide technical support and is required to follow up on stability studies linked to projects. Customer collaboration is at the heart of his job.