Archive for December 2018

Finer Tones in the Regulatory Affairs

The regulatory affairs specialist or attaché is responsible for implementing actions to ensure the regulatory compliance of the company’s products.

For a new product, the specialist or attaché affairs regulatory is in charge of the constitution and drafting of the regulatory file or homologation file. It provides operational support to all the teams involved in setting up this file and in particular the R & D, development, production, quality and marketing teams. He writes the internal procedures. From the Regulatory Affairs Consultant this is a very important matter.

  • It ensures the filing with the regulatory authorities and the follow-up of the registration steps.
  • For a product already on the market, it prepares all the elements to ensure the renewal of marketing authorizations.

Double competence

The specialist or attaché affairs regulator relies on a dual competence, scientific in the field considered and legal to control all regulatory aspects. He must be organized, rigorous, a good negotiator and a good writer.

Where does he work?

He can work in a company (this is the case for large companies), for an external firm or in a regulatory body.

Specificities of the training

The specialist or attaché affairs regulatory have a formation BAC + 5 (engineer, master or doctorate in the considered scientific field + formation legal).

Every business is required to follow certain rules. In addition, you must comply with certain regulations and standards to maintain your commitments, and increase the efficiency and credibility of your business.

Regulations and standards vary from one industry sector to another, and are often specific to certain business activities. These regulations and standards may change over time; it is therefore important to be on the lookout for news.

Learn about the regulations and standards that apply to your business.

Regulated business activities

Learn about regulations that apply to key business activities such as exporting, importing, marketing, and managing employees.

Regulated sectors

Learn about how certain industry sectors are regulated and what are the key obligations of companies that are operating in these sectors.

Regulatory changes

Be on the lookout for proposed regulatory changes that could affect your business and see how you can influence these changes.

Find out what standards your company might follow to improve your products and services, or to increase your productivity.

Business Navigators

  • Get individual help to find out what permits and licenses are needed to operate your business in Nova Scotia and what regulations apply.
  • The regulation on the layout of the premises is most abundant. This is not a reason to ignore it. Do with us your inventory.

Do you develop or remodel your premises?

Welcome to the country of standards! Companies must, in fact, comply with a multitude of texts on health and safety. And better not to take them lightly because, in case of slippage, the note can be heavy for the employer. In the best of cases, the occupational doctor, alerted for example by an employee, can come to visit the premises and demand that the ventilation of a workshop or the lighting of an office be improved. In the worst-case scenario, a workplace accident, judges are more likely to question the manager’s responsibility for neglecting a planning standard.

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