The Regulatory Affairs Consultant implements the company’s technical and regulatory strategy to ensure the application of regulations for the development, marketing and distribution of health products. It performs all activities related to registration, marketing authorizations (MA) or CE marking, registration in exporting countries.
With the current regulatory framework increasingly complex and rapidly changing, many companies choose to outsource companies to carry the regulatory issues of Medical Devices and quality assurance tasks as a way to ensure compliance.
- Definition and implementation of a regulatory strategy
- Confer with the research teams, the marketing and quality department, in order to comprehend the distinctiveness of the developed product
- Describe a regulatory strategy consistent with the commercial policy and R & D of the company
- Provide operational support to all internal departments to guarantee the proper application of quality protocols, in a permanent effort to comply with the quality and safety requirements for placing on the market
- Make recommendations to the different departments to ensure professional ethics
- Participate in the choice of registration strategies for the product portfolio of the company
Drafting and monitoring of regulatory files:
- Ensure product access to the market by taking the necessary regulatory steps: obtaining, modifying and maintaining marketing authorizations
- Collect, from the R & D departments, tests and trials and production, the various types of technical documentation in order to constitute the regulatory files
- Animate preparation meetings for all registration dossiers
- Write registration and marketing authorization dossiers and file them with regulatory authorities
- Track registration files and registration processes with ministries
Variability of activities
The activities of the Regulatory Affairs Consultant differ according to whether he or she is practicing in a company, a firm or a regulatory body.
In business, he intervenes more upstream of the commercial policy with the sales and marketing teams. It is a force of proposal to them, in particular as regards the anticipation of the regulations and norms in the field of activity of the company. Within an SME, he has a strong role in the monitoring and control of production quality, especially in the use of raw materials and production processes. In a large group, his mission is more focused on the regulatory strategy of the company at national or international level. He then holds the title of Director of Regulatory Affairs and is responsible for supervising regulatory officers. In this context, he is actively involved in the communication policy towards regulatory bodies and may be required to represent his company at conferences or conferences.
In a consulting firm in regulatory affairs, the Regulatory Affairs Consultant has a role of greater legal advice to companies. Some of them do not have an important legal structure and seek advice from law firms for their legal strategy. Its versatility is stronger because it intervenes in various industrial fields and with companies of very different sizes.