Regulatory Affairs Represents a Safe Haven in an Economic Storm
For the fourth quarter of 2011 the name of the game for regulatory affairs recruitment has been consistency. Whilst the number of positions available at the start of the quarter suggested the beginnings of an upward curve, this has since levelled out. ProClinical’s assessment is that this is par for the course at this late stage of the year.
On the permanent side of things, there are ongoing opportunities for specialists in the areas of centralised registrations, targeting those experienced in the workings of the European Medicines Agency. Also highly sought after are those with knowledge of chemistry, manufacturing and controls (CMC) (Module 3), licence transfers/change of ownership applications and – an ongoing theme – emerging markets. In addition to this, there have been a number of vacancies in clinical development, specifically on the part of CROs – more so at the later stages of 2011 than in previous quarters.
There continues to be a hunger for people with emerging market experience, still regarded as a niche skill set. With these candidates clearly standing out from the crowd, it is becoming increasingly evident that this is the direction that companies are taking in order to guard against stagnation in traditional markets and ensure sustainability in the longer term. Knowledge of regulatory affairs in the Asia-Pacific region, including China and Singapore, the Middle East, and to a less extent South America, is particularly desirable at the moment.
Contract placements have had an extremely robust start to the quarter – building on 34 contracts in Q3 – and have otherwise been fairly steady. As with the permanent sector, CMC remains desirable, as companies strive to achieve faster results. Expertise in licensing, change of ownership and variations are similarly sought after. With EU medicines agencies seeking to introduced mandatory electronic submissions – for example, Portugal will have this in place for 1 January 2012 – companies are seeking candidates with expertise in eCTD.
However, there are signs that overall demand is tailing off towards the end of the year , making this a quieter period than previous years. Certainly during the last quarter of 2010, there has been a marked increase in the demand for temporary contract workers, leading to a shortage of talent and a hike in pay rates. These vacancies have spilled over into 2012, but there are also early signs of a slowdown, indicating that uncertainty in Europe and the negative economic environment may be starting to bite.
At the same time, being in regulatory affairs during this period is likely to be a boon. As companies are faced with increasing competition for limited funds and more demands for comprehensive data from authorities, bringing a product faster to market is going to be a key element for overall success.
All Regulatory Opportunities