Thursday, April 24, 2014
Skill Requirements for the Regulatory Affairs Function
In an ongoing effort to keep our clients and candidates informed of job market trends specific to their function, we have highlighted 5 areas where this demand for skills and experience is most acute, giving companies recruitment challenges and candidates opportunities.
The of the BRICS and the Next 11 emerging economies have created new commercial priorities for pharmaceutical companies. While macro-economic have created some recent economic weakness in these markets, the long term trend is towards considerable growth. This new commercial importance has placed considerable emphasis on ensuring the right regulatory leadership is in place to drive optimal drug approvals in emerging markets. Equally, companies are adapting to new operational models with more expertise being placed closer to the markets themselves. Finally, the global leadership of a regulatory function in coming years will almost certainly demand emerging markets experience in the experience profile of the appointee, placing a strategic incentive on acquiring that experience if you are ambitious for future leadership roles.
were the story of 2013. Quite simply this sector is hot, and whether it is rare cancers or other rare genetic disorders, the orphan drug sector is experiencing considerable innovation and investment. With a rapidly developing global pipeline of new innovative therapies aimed at the 7000+ rare diseases, experienced regulatory professionals who understand the orphan drug designation process and perhaps have already assimilated the knowledge around recent initiatives like the FDA’s breakthrough therapy, PDUFA derived from FDASIA, suddenly find themselves in considerable demand. These people are experienced in conducting constructive dialogue with agencies to look for effective pathways for approval of new and innovative therapies for treating rare and ultra-rare diseases.
Biosimilars has seen considerable investment in recent years. While the biosimilars story is nothing new, the focus it is now receiving in multiple large innovative pharma companies is placing greater and greater emphasis on surrounding these investments and business units with the qualified expertise required to carry out effective biosimilar development. Liftstream forecasts that in 2014/15, the market will see an inflection in biosimilars recruitment and the global innovator companies are to lead this growth. In particular, companies with considerable experience in biologics drug development and manufacturing will be most visible. Regulatory Affairs professionals with specific expertise and experience of the biosimilars regulations and the manufacturing challenges will be in increasing demand for both their conceptual and practical knowledge.
There are several underlying reasons for the increase in skill specificity. Liftstream would be pleased to talk you through those reasons if you have a genuine interest. The most simple to convey though is that in general terms companies need people to bring very specific capabilities which can be applied almost instantly to the projects or tasks to be delivered. This does not afford the degree of cross-training or ‘development’ that is often thought of when considering to apply for new jobs. Employers are also responding to a need to see the value of employees returning sooner, as employee retention is on a long-term declining average and the market becomes more competitive as the economy improves. One of the outcomes of this is simply that regulatory affairs professionals are being recruited increasingly to have disease area specificity. This is particularly true in areas like oncology, CNS, immunology and many rare metabolic disorders. This trend is set to continue and disease experts will be highly sought after.
Successful clinical and regulatory affairs strategies are only part of the story these days. The third and increasingly high-hurdle is the payer challenge. Getting pricing and reimbursement for new therapeutic products is proving very difficult, especially in Europe, and only highly innovative therapies with are first in class and best in class are commanding their prices and achieving access. Liftstream believes that the increasing convergence of the world of regulatory with market access is set to continue. Multi-stakeholder dialogue is a new imperative in planning clinical development. These new and critical strategies must be integrated and so regulatory affairs professionals are going to be increasing exposed to responsibilities. The next 5-10 years provides an excellent opportunity for regulatory professionals to use this momentum in market access to create a new career pathway for themselves as either responsibilities morph together or you acquire skills which open new avenues.
If you would like to conduct a review of your regulatory affairs recruiting strategy or would be interested in discussing your career plan, please contact Liftstreamfor a confidential consultation.
Pharmacy, Life Sciences, Biotech, Medical Professionals can update their knowledge to enter into world of Regulatory Affairs by joining course at IBRI,Noida www.ibri.org.in