The role of Regulatory Affairs professionals is sometimes misunderstood, even by business owners and hiring managers. Those organisations that fully understand the importance of excellent Regulatory Affairs professionals tend to be successful and navigate with ease through the complicated regulatory environment. So how exactly can a great Regulatory Affairs professional contribute to your organisation?
The ideal regulatory person should be your ally, strategist, leader and a pleasant person to work with. Since we don’t live in an ideal world, hiring a good regulatory person is often a result of urgency, available budget, business climate and available pool of candidates. However, this doesn’t mean that companies have no choice in finding and keeping the best regulatory talent. Some of the benefits of having a great Regulatory Affairs professional by your side are:
This is namely done through good negotiation with partners and authorities. Not all activities should be performed right away and before the marketing authorization application- some are mandatory but some are `nice to have`.
Depending on the drug and the targeted disease, different timings for the authority interactions are advisable- sometimes as early as possible but sometimes a later interaction might be more beneficial. Your situation might benefit from the PRIME scheme or, perhaps, from the new tailored scientific advice for biosimilars which are both quite new services offered by the EMA. Good and experienced regulatory people know how to properly time authority interactions.
Not everything is firmly set in legislation and guidelines. They require interpretation and case-by-case implementation. Great people know how to creatively find adequate solutions to keep your company in compliance and hopefully ahead of your goals.
Depending on your organization´s size and goals some tasks could be outsourced and some insourced. Not all outsourcing is bad and not all insourcing is good. I have worked with organizations that refrain from outsourcing to freelancers or specialized service providers for all wrong reasons or reasons based on one person´s opinion. Their insourcing principle also led to wrong decisions and ultimate overspending and frustration.
All these activities should lead to shorter development timelines, regulatory compliance, good risk management and hopefully budget savings.
On the contrary, if your regulatory department is inexperienced or not appreciated enough by the management many unwanted events can occur.
These are the examples of the possible late-surprises you want to avoid:
Performing too many `nice to have` studies before your marketing authorisation while those could be performed also afterwards;
Realizing you are late with or, even worse, you completely missed to submit your Pediatric Plan;
Realizing your drug requires a detailed abuse liability testing before your marketing authorization submission;
Late realization that your documents in a submission dossier are not technically compliant, adequately translated or in an adequate format;
Forgetting or not fulfilling prior authority commitments.
Excellent Regulatory Affairs professionals are crucial to your organizational success. Hiring and keeping Regulatory Affairs professionals is a task that requires planning and management commitment. Right Regulatory Affairs people are great investment and all time and resources invested in finding and keeping them creates a tremendous value in the long run.