The pace of change and the many requirements affecting all those working in the life sciences industry have never been higher, particularly with regards to the regulatory function.
Where, historically, regulatory personnel may have been seen as working in silos – both geographically and functionally – today, with industry regulations continuing to change globally, regionally and locally, regulatory affairs now sit right at the heart of business strategy. The ability of companies to attract, develop and retain highly knowledgeable and skilled regulatory professionals is critical for current and future business success.
Despite the activities of dossier preparation, submission and gaining approval still being key requirements of the regulatory function, they are by no means the sole purpose. Companies now require regulatory professionals who can demonstrate experience and success in delivering progressive regulatory strategies across multiple geographies; professionals who have knowledge, understanding and access to key decision-makers and influencers in regulatory authorities, as well as to commercial acumen, and the ability to translate value and risk of regulatory strategies to the broader business.
Finding the right people
Although companies require individuals who understand the science and regulatory aspects of the business, a key differentiator between good and great regulatory professionals is highly developed soft skills. Companies are in urgent need of regulatory professionals who can combine their technical background with these soft skills to create robust regulatory strategies and pathways that they can effectively engage on and communicate to multiple stakeholders internally and externally. Companies are looking for people who have the ability to persuade and influence across functions, levels, cultures and geographies, and who are flexible, creative and good at problem-solving.
Todd Chermak, Divisional Vice President of Abbott Nutrition Regulatory Affairs, believes that it is “not simply around submission activities anymore; regulatory professionals are expected to be an ambassador for the company, a relationship builder, and a messenger who is able to influence and change external environments.”
Chermak continues: “Regulatory professionals need to have a bit of everything. Companies are looking for individuals who know how to be a good business partner and contribute ideas; individuals who have a commercial mind-set, understand the client and the value of what the client brings to the marketplace; someone with great negotiation and communication skills, because they will be interfacing with regulatoryand policy-makers. Today’s regulatory professional is not just a gatekeeper or checker, but rather a professional who generates ideas. Attracting such talent is one of our biggest challenges.”
Talent within regulatory affairs is scarce across all segments of the life sciences industry – be it pharmaceuticals, medical devices, nutrition, over-the-counter, animal health, generics or diagnostics – and the competition to attract and retain personnel is high and growing. Historically, the pharmaceutical industry was the number one choice for a lot of regulatory professionals as opposed to other segments. However, regulatory professionals want to work with ‘interesting’ products, and these other segments and the pace at which product registrations take place means these sectors are now viewed as exciting and stimulating fields to be in.
“Although many professionals in the life sciences sector perceive the pharmaceutical industry as being the premier part of their career… we have started to see migration, with people moving from pharmaceuticals to nutrition,” says Chermak. “Personally I find the nutrition side of the business more challenging, fascinating and rewarding, in terms of being able to have an impact on the marketplace. In addition, product cycle times are much shorter than with new chemical entities, so it is not uncommon to see something you are working on today come to market in three to five years.”
When it comes to their working lives, regulatory professionals want visible, well-defined career pathways, and opportunities for progression and promotion. They want support (both financially and in terms of time) to learn, develop and grow, both their geographic and people responsibilities; and recognition of the strategic role they play within the business.
To facilitate and support both personal and business ambitions and needs, more employers are engaging in clear, structured, individual and realistic personal development plans that link ongoing training and education needs into their corporate succession planning processes. It is not enough to complete an appraisal once a year as a ‘tick box’ exercise and then let it sit on a shelf, only to be dusted down when the time comes around again. Managers and their reports need to be engaging in a regular ongoing dialogue, and this requires time and commitment from both sides.
Bridging skill gaps
“Abbott Nutrition has developed courses with human resources on topics such as negotiation, critical thinking and decision making which have proved to be very successful,” says Chermak. “We have also looked at customised development programmes because every individual is different. Some people might have MBAs but need to focus on negotiation skills; so we ascertain their needs and enrol them on internal or external programmes to develop their skillset. Although our courses help give foundational learning, convention suggests 70 per cent of one’s learning is experiential. We believe that what makes people successful is giving them those experiences; allowing them to partner with somebody, or rotating them throughout different parts of the business.”
One of the most common challenges facing regulatory professionals when it comes to career development is that regulatory experience may historically have been perceived as a relatively narrow area. Regulatory professionals need to break out of this mould and start asking: “How do I become a business leader?”
“A commercial leader is often viewed as a business leader,” Chermak reasons. “I don’t think people always look at regulatory professionals and see talent for new business leaders. Regulatory heads need to do what operations did, and help create a pipeline of business leaders who can be relied on and who are recognised for delivering for the organisation. Regulatory professionals have such diverse skillsets, in addition to their understanding of regulatory, which not many other people in a company will have. Our biggest challenge is to reinvent ourselves to be great business leaders so that in the future when there is a senior level opening, regulatory professionals are considered.”
Retention of regulatory talent has increasingly become a key focus for companies due to increased demand for this highly-prized ‘population’, which outstrips supply. Employee engagement, effective succession planning and company culture are all key factors that heavily influence candidates’ thinking and decision-making when it comes to staying with or leaving their current organisation.
“There is a long incubation period for regulatory professionals because there is a lot one needs to learn to be successful,” says Chermak. “Once we make that investment in an individual, to lose that talent after developing and training is devastating. Talent retention is critical and although we work a lot with human resources on the development side, the day-to-day dealings with partners in commercial and R&D are vital because they create the interesting environment for our people to be a part of.
“People love to be part of a team that is built. The collaboration between multi-functional teams and the environment that says ‘we equally value your ideas and contribution to the business,’ creates a rewarding situation.”
For life sciences companies in search of this new ‘super-breed’ of regulatory professionals, it is clear that attracting, developing and retaining top talent are all interdependent. People do not become great regulators in just one or two years. But with patience, commitment, determination and critical thinking from both employers and employees, regulatory professionals can become true business leaders.