When I used to work in big corporations in the regulatory department, the mindset was to do what we need to do in our department and we don’t really need to know so much about the other operations of the company. Apart from dealing with close deadlines, we would have to manage our “commercial colleagues” whom from time to time would hound us for approval dates and whether we can speed things up. Confinement to our own desk within our department with little understanding on the commercial end was the take home message for me. At that point of time, complying to the regulations strictly with no flexibility was the core value I held on to. So does Regulatory people need to be commercially sound too?
The answer is “Yes”. Very often, each regulatory decision will affect the business commercially. Take for example, a site change variation will affect the timeline in which the goods can be supplied to the clients . Without any awareness of the impact on the business as well as proper planning to do the site change variation, we will inadvertently contribute to the drop in sales for that few months and allow other competitors to grab the sales. The second example : during the planning of a launch of a product in multiple countries, if regulatory personnel does not understand the timeline of what the commercial has in plan, the launch of a product will likely end up to not be in sync with the marketing plan. This will greatly affect the opportunity cost for the product to gain market share substantially.
What are the benefits then for a regulatory personnel to be commercially sound? A commercially savvy regulatory personnel will be able to foresee the business cost in each action he or she takes. Like in the case of a site change variation, the regulatory personnel is now aware that it will take about 6 months for approval and therefore will inform the commercial side regarding the impact on the stocks supply and hence allowing the commercial side to mitigate the stock issue earlier by ensuring that they will take in more buffer to last them till approval is obtained. If a regulation is passed down, the regulatory personnel will be able to interpret and understand how to incorporate it into practice without affecting the business. The regulatory personnel will be able to advise the company the best way to approach regulations and turn it into a business plus point to the clients. Say in the case of a new requirement to submit voluntary applications for a product, the regulatory personnel will be able to inform the commercial side on the decision to submit as many voluntary applications as possible. This will provide an added assurance to the company image on doing their best to comply with the regulations as well as supplying of quality and safe products. This could also eventually provide a reduced timeline in getting the product licence’s approval when the regulations tighten since the products has went through an initial phase of voluntary registrations.
Being commercially savvy will allow regulatory personnel to consider the business cost at hand and also allow them to advise on a possible business opportunity to enter new market and provide alternatives for launch of a product. As I always described, regulatory personnel is the stronghold to the success of a business. They are the ones that will ensure that products get marketing authorization . They are also the ones that will ensure that each business decision will be in compliance with the regulations to ensure the smooth operation of the business.