The 2012 Scope of Practice and Compensation report – surveyed more than 3,000 regulatory workers in 58 countries – found that regulatory workers are now expected to have expertise in the entire life cycle of a drug, and are playing a bigger part in forming overall business strategy.
And with an ever increasing amount of pressure to stay compliant, RAPS (the Regulatory Affairs Professionals Society) says companies are willing to shell out more to keep staff happy.
Speaking to in-PharmaTechnologist.com, RAPS executive director Sherry Keramidas said: “Companies may cut corners price wise in other areas, but cutting the regulatory professionals could mean the loss of the product.
“Regulatory professionals are definitely taking on more work. Over the last 10 to 15 years we’ve seen them taking on roles throughout the product lifecycle and transitioning from purely regulatory to policy making and decision roles, and I think we’re seeing a shift toward a life cycle view of regulatory management now.”
Keramidas said however that the demand for a broader knowledge is less common within Big Pharma, especially at the lower levels, because they can afford to pay more staff to specialise in certain areas.
“People working for small to medium enterprises (SMEs) or people in biologics firms are more likely to be less specialised and be more broad scope,” she added, saying that with less money lesser companies cannot afford the same level of staff.
Conversely, Keramidas said she does not expect people in management and business decision making roles to take on more regulatory work, because often they do not come from a scientific background.
She said: “I think when you get to manager, director, VP level, they will understand regulatory aspects, but we’re finding that regulatory experts normally combine a background of skills from other areas along with regulatory knowledge and business sense.
“It’s very hard for business managers to know the subtleties of science in the regulatory game.”
The report also found that on average professionals in the US or Europe have more experience than those in emerging markets – something Keramidas put down to the fact the regulatory role is “younger” in BRIC countries.
She said however that RAPS is working with a number of regulatory bodies including the World Health Organisation (WHO) and the US Food and Drug Administration (FDA) to boost capabilities in emerging countries.
She added that all have high hopes for the Regulatory Affairs Certification (RAC) – a post-academic credential for regulatory individuals.
“There are now a number of regulatory agencies looking at how this might increase staff knowledge in the emerging markets,” she said. “I think it can help to elevate problems in developing markets because it definitely highlights whether the professional has the core competencies and skills.”