Regulations in the pharmaceutical sector are serious!

Before a medicine or treatment can be marketed, companies in the pharmaceutical sector have to comply with the regulations in force in Canada. What do those responsible for regulatory affairs do?

For pharmaceutical companies, having Health Canada quickly approve their new drugs or changes to their products is the critical factor. The sooner the product is approved, the better it is for business. No detail can be neglected. A regulatory affairs specialist or partner is therefore a key position, which requires both great scientific rigour and a certain business sense.

Concretely, the regulation specialist must prepare all the technical and pharmaceutical documentation presented to Health Canada. The government organization is the only authority empowered to analyze submissions from pharmaceutical companies when they are ready to market a new product. “It’s a highly specialized profession, involving high levels of pharmaceutical knowledge and an  understanding of Canadian laws,” explains Chantal Fillion, principal partner of the St-Amour recruitment firm, which specializes in the pharmaceutical sector, among others.

A versatile scientist

Since the application for approval of a drug is a scientifically rigorous process, the regulatory affairs specialist is a real scientist, whose knowledge of the pharmaceutical industry is at his fingertips and who knows how to talk to laboratory researchers. “Many of the specialists we hire have also worked in the laboratory for several years before getting into the profession,” says Chantal Fillion. “It goes without saying that most of them have a masters degree or doctorate in chemistry or biochemistry.”

Marketing skills are also desirables, because many second-level specialists may be called upon to reflect on the company’s business strategies or support internal teams in their preparation to market a new product.

A skillful diplomat

“The regulatory affairs specialist is also a good communicator and a great diplomat,” emphasizes Chantal Fillion. He is in fact at the centre of the process for marketing a drug, called upon to get in contact with both senior management and with the laboratory and quality control staff, as well as the marketing department, not to mention his government counterparts who use different codes of communication.

“And that goes beyond the strict regulatory control of drugs,” adds Chantal Fillion. “Health Canada is also involved in a change of infrastructure within a pharmaceutical company, for example. The regulatory affairs specialist remains its main point of contact at all times.”

Are you this rare gem? “Candidates are not always easy to find; it needs excellent headhunters,” confides Chantal Fillion.

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