Regulatory Affairs Job Trends from MassBioEd

Jan 18, 2017

Since the outset of 2016, we at MassBioEd have continually looked to our human resource professionals in the industry and asked, “What workforce issues keep you up at night?” We conducted a survey last May and identified problem areas for which hiring managers are having a tough time finding enough qualified candidates. Foremost among their responses was . . . Regulatory Affairs.

Since 2012, those employed within regulatory positions at biopharma companies in Massachusetts rose at an annual rate of 18%, from 624 to 1,027 – an increase of 403 in three short years. Increases in demand are heightened  by the fact that training and development of regulatory professionals is unlike that of most other core positions in the industry, which have a constant pipeline of new college graduates willing and able to fill the voids. For the most part, regulatory affairs workers are  developed and molded from the ground up, within companies.

The latest in our Briefs series on industry job trends, Insight on Regulatory Affairs, was released on January 18th, 2017 . It shines a light on the job market for regulatory professionals in biopharma, identifies areas of concern, and proposes solutions that will ease the development of qualified candidates to fill these openings. On January 26th, MassBio hosted a thought-provoking forum, Regulatory Affairs: Find, Hire, Retain, in which experts from across industry and academia will be catalyzing a discussion on these very topics.

So what were our preliminary findings?

For one, we learned that the problem isn’t finding workers for entry-level roles. Incumbent workers are more than willing to switch from their current quality control or bench scientist roles, for example, into entry level regulatory positions, as they are already familiar with the regulatory regimes governing the products upon which they work. About only 10% of regulatory professionals workers get their start in regulatory affairs without first making a pit stop in another functional area. In fact, this eagerness to transition from other fields within industry to regulatory has resulted in the base compensation declining for lower-level regulatory workers since 2012, with real wages declining by approximately 7%. This would not happen if companies were locked in heated competition for a limited pool of qualified entry level workers.

Instead, the strain on regulatory hiring is at more senior levels and results from a combination of factors. With most training internalized for regulatory positions in the industry, senior regulatory officers are in greater demand which pits company versus company for these valuable professionals.  As gaining entry into regulatory roles from within the industry is the common practice –there exists only limited external coursework and training in regulatory studies, and nothing beneath the limited existing graduate level offerings. In a state with some of the highest concentrations of regulatory professionals, there are only three universities that offer graduate degrees or certificates in Massachusetts – Northeastern, Regis, and MCPHS.  

Any solutions?

There are no industries more highly regulated than the life sciences. So, any means by which the strain on hiring regulatory professionals at experienced levels should be explored.  In the end, more skilled professionals mean an eased regulatory process for any company, ultimately meaning more life changing products reaching the bedside at a faster rate.

Increased offerings of broad spectrum  courses in the fundamentals of regulatory science would be of huge benefit to workers looking to transition into the field and increase their effectiveness in these roles.  In collaboration with Regis University, MassBioEd will be offering a Health Products Regulation course, at low cost for MassBio members, beginning February 8th to help fill this need.  Such course offerings, offered on a broader basis, should be effective in increasing the requisite understanding of core regulatory concepts for workers transitioning into the field from other work roles.  

The local graduate programs that do exist provide valuable resources for companies and employees to explore for skill enhancements of mid-level and senior professionals in regulatory affairs.  

The competition for experienced regulatory affairs professionals will not recede overnight. As the local industry continues to mature, these roles will continue to be in high demand.  Increased offerings in external training, as well as third-party training done in-house in both general and specialized skill areas will increase the volume of qualified specialists in this critical field.  


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