By Scott Jackson, Vice President
As an executive search professional specialized in RA/QA, I firmly believe – and the most competitive CEO’s agree – that regulatory strategy should be a key component of the overall corporate strategy. Creating the right emphasis and goals for each department is critical for all product development companies within life sciences, and regulatory expertise is invaluable in securing regulatory approval – the company’s future is riding on it.
Over the past 5+ years there has even been a rise in the Chief Regulatory Officer title, with examples from both public and private companies at various stages including: Vertex Pharmaceuticals, Flexion Therapeutics, Prothena, Neurocrine Biosciences, Encoded Therapeutics, CymaBay, Emulate Therapeutics, Alnylam, Kaleido Biosciences, Quark Pharmaceuticals, Albireo. Most multinational firms have dedicated Regulatory Affairs (RA) departments, within their internal organizations.
As innovation speeds up and regulatory agencies work to keep up with industry, the importance of regulatory affairs is highlighted more than ever . Most companies’ boards and executive teams agree that regulators should be at the executive level and participate in the drug discovery process as early as possible. They want to be sure to include their perspective on the development path for investigational new drugs. Great regulators can save you time and money.
Title Considerations: To attract the best Regulatory executives from the pool of candidates that have novel new drug approvals under their belt, we recommend more companies seriously consider the Chief Regulatory Officer designation as a good way to demonstrate how much regulatory affairs professionals are valued by their organization. Not only is this a great tool to attract talent, but it also aids in retaining the talent they currently have by offering career growth for their acting regulatory leaders.
Reporting Structure: There is no steadfast formula for where the Regulatory Affairs department sits within an organization. From an organizational standpoint, within smaller companies that are in the clinical development phase without commercial products, the Regulators commonly report to the Chief Executive Officer. In our experience, well-financed companies typically insist on having this expertise “in house”, since outsourcing and less focus here has proven less than ideal.
In large multinational companies, however, it not typical to have Regulatory in the C-suite, or even reporting to the C-suite. In these larger companies, RA can be positioned in several ways. This includes within specific business units or therapeutic areas, by country or region with specific regulatory experts reporting to a global function supporting Research & Development, or under the Chief Medical Officer.
Building your Regulatory Team: Building a Regulatory Affairs team is no easy task. Most companies want us to identify a regulatory professional who has recently done something novel that parallels their situation, which can be a challenging undertaking. The US Food and Drug Administration, specifically CDER, has an annual report on Novel Drug Approvals that is publicly available. On average, for each year over the last 5 years, (2015-2019), there have been 44 novel drugs included in the report. When one considers the limited number of novel new drugs, then layering on the appropriate modalities, therapeutic indication and stage / size of company that they come from, there are indeed very few candidates that will meet a company’s exact profile and expectations. Not to mention location!
Additional Search Challenges: Most regulatory professionals are by nature risk averse, which makes the likelihood of them moving to a new company somewhat lower than that of other candidates. Also, many companies are offering lateral moves because regulatory has reached a peak internally, and therefore they are seeking a step in the right direction. In my experience, most aspire to have a seat at the executive committee level. These challenges add to the complexity of building a regulatory team and ensuring you have the right people in the right roles, particularly at the highest level where leadership and strategic thinking is extremely critical. Finding the right person can be painstaking and very time consuming which is why it is quite common that these searches require our assistance as regulatory search professionals.
For more information or assistance on building your internal Regulatory & Quality Group, or for career guidance for Regulatory or Quality professionals considering a change, please feel free to reach out to me at firstname.lastname@example.org. I welcome your comments and questions.