The growing role of regulatory affairs
pharmafile | June 30, 2011 | Feature | Business Services, Research and Development, Sales and Marketing | regulatory affairs, topra
Some years ago, regulatory affairs (RA) was seen by some as merely a ‘front office’ function, providing a necessary interface between the scientists in pharma companies and the regulators.
Today, things are very different, and regulatory affairs is now a respected discipline in its own right. Regulatory affairs personnel are key members of the cross-functional teams in pharma which manage products before and after launch.
At the core of regulatory affairs work is keeping marketing authorisations (MAs) up-to-date with the latest safety, efficacy and quality requirements of regulators and the many consequences of lifecycle management.
But now the breadth and range of issues covered by RA has expanded greatly, thanks to developing science and also in the large part due to the increasing demands made by medicines regulators on licence holders.
The last decade has seen the growth in a range of areas – paediatric requirements, pharmacovigilance and health technology assessment (HTA) among others.
Lynda Wight is executive director at TOPRA (The Organisation for Professionals in Regulatory Affairs). Asked whether this growing regulatory burden explained the rise of regulatory affairs, she said:
“I don’t particularly like the phrase ‘regulatory burden’ – but it is true that medicine and the science behind it is evolving. So as more new science comes to the fore, there has to be new ways of assessing it. That creates complexity, and we need people who can focus on understanding and managing the processes.”
What makes a good regulatory affairs executive?
“The key to being a good regulatory professional is to be confident in your science,” says Lynda.
“You will be faced with a huge breadth of demanding science – from statistics to toxicology to pharmacovigilance and so forth. No academic training can encompass all these disciplines, so you have to be able to take on all this information and assimilate it.
“You have to be a confident scientist and say, yes, I can get my head round all that information in all those specialist areas.” Moreover, being part of a cross-functional team means having to negotiate internally. Regulatory affairs was once seen as being removed from the commercial pressures on the marketing team, but RA executives must now also bear in mind the business interests as well as regulators’ demands.
Traditionally, regulatory affairs staff were almost exclusively drawn from the pharmacy profession, but now with the expansion in other biomedical degrees and training, pharmacists may only account for around one-third of RA professionals.
Experience needed
A good degree in a relevant medical science is the normal prerequisite for a career in the field, and a significant proportion of RA professionals have a second degree. However, awareness of regulatory affairs among undergraduates is very low.
TOPRA is trying to increase the profession’s profile within these groups, and works with universities to promote the opportunities of such a career.
Another barrier to getting new graduate talent into the field is that most job adverts ask for several years of experience. This has been a long running problem for graduates wanting to break into regulatory affairs.
TOPRA is now investigating how best to help its student members by helping to arrange internships or short term contracts.
There are numerous full-time regulatory affairs masters courses run in the US and Europe. TOPRA runs its own part-time courses, which can be undertaken while in work including an MSc in regulatory affairs and an MSc in Medical Technology Regulatory Affairs, both validated by internationally recognised universities.
Moving from other jobs in pharma
So if regulatory affairs is growing in importance within pharma, is it a safe haven from all the cuts being made in other departments? The answer, sadly, is no, but demand for well qualified and talented people to work in RA is strong.
“I do hear about jobs being cut in regulatory affairs, but then I don’t hear about a lot of people who are out of work for very long,” says Lynda. “There are other opportunities available, if not in pharma itself then in consultancies, for instance.”
The perception that a move into regulatory affairs is difficult and that existing skills may not be valued persists, but this is not necessarily the case.
People who have found themselves redundant in other areas of the business could find their skills valued in RA.
People moving from within pharma might typically come from a lab-based job, or from medical writing, or a clinical research monitoring role.
“There are lots of ways in. If you have worked in a pharma company, you get to understand the drug development process. Even if you are only working in one particular part of it, you get to understand the regulatory imperative and demands. This can increase your understanding and give you a head start in breaking into the profession.”
Lynda says there were many preconceptions and misunderstandings about regulatory affairs people in the past, but that these are slowly changing.
“Regulatory affairs were traditionally seen as being risk averse, as not understanding the commercial demands, seen as nitpicking, all those sorts of things -that’s changing.
“The best regulatory people today not only have a strong grasp on the science and regulatory requirements, but have strategic and commercial awareness, they work in teams, and they manage projects,” she says.
“That’s because the industry is changing and therefore these roles and the people in these roles are changing as well.”
There are many regulatory affairs jobs on InPharm and more details about TOPRA’s role and courses can be found at www.topra.org
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