Cheat-sheet for finding excellent Regulatory Affairs Experts
Finding extraordinary Regulatory Affairs experts who are flexible, knowledgeable and experienced is not an easy task. Luckily there are some proven methods and “cheats” that can help you find your Regulatory expert without a headache.
You really want to look for a company that has a vast experience in Regulatory Affairs and experts who understand your specific regulatory needs.
Avoid service providers who don’t understand the nuances and complexity of the Regulatory Affairs field, especially in your therapeutic area or product class.
For example, if your product is an orphan medicinal product make sure your Regulatory Affairs Expert understands specific development challenges related to these products.
Don’t forget to ask about timelines and set clear deadlines. Great Regulatory Affairs experts will ensure you meet all requirements while developing your products. Ideal Regulatory Affairs provider should be able to provide ad-hoc, short and long-term support, depending on your goals.
2. Be precise, expect questions
When describing your unique Regulatory challenges be very specific. Good Regulatory expert will try to understand the specific Regulatory issues your company is facing. Every company has a different set of Regulatory challenges. Be vary of the “one size fits all” solutions.
Listen carefully to the questions a Regulatory Affairs expert has about your product. Are they rather general or hitting the right spot? This will give you an idea about the expert’s experience with the topic.
Also, it is smart to choose a staggered approach, pre-define “check points” where your decision to continue with a Regulatory Affairs expert depends on the quality of the deliverables and your general satisfaction. Flexibility is the key to your success, and you should demand it.
3. You need someone to coordinate things
Whether you already have Regulatory expertise in-house or you expect your Regulatory consultants to provide the requested expertise, don’t forget to coordinate. Lack of coordination can lead to confusion and uncoordinated execution leads to a disaster.
4. Check frequently, ask for updates
Weekly or daily updates and clear task assignments are crucial when working on important Regulatory tasks. The situation you want to avoid is to realize too late that your Regulatory strategy has a big flaw, which could have been prevented and identified much earlier.
Responsiveness of a Regulatory Affairs expert to your questions is one of the key indicators of a good expert. Is this expert difficult to reach, either via phone or email? You better think twice before hiring him.
You should work only with professionals who are fast and truly dedicated to assigned projects.
5. Be transparent, expect transparency
You should communicate both goods and bads of your product development to your Regulatory Affairs Expert. In return, you should make clear that you expect the same when it comes to the Regulatory matters and opportunities. This is the only way to ensure success.
6. There is no obstacle too great
Carefully observe how the Regulatory Affairs expert handles difficult questions: with confidence or acts insecure. It is very difficult to find a Regulatory expert who has done everything in Regulatory Affairs and therefore it is important to search for a confident and honest person who gives assurance that every regulatory obstacle can be overcome.
There are numerous tough Regulatory situations you would require your Regulatory Affairs expert to properly manage (for example, tough discussions with Regulatory Agencies, especially if your product is very innovative and there is a considerable level of uncertainty). It is absolutely crucial to have an experienced, confident and honest Regulatory Affairs expert on board to help you in these situations.