September 23, 2015
Innovation is essential for the life sciences industry. Dr. Sarfaraz Niaz, founder and Chairman of TheraProteins (TPI), a biosimilar company located in Chicago, explained it perfectly: “You should never get enamoured by your thoughts. If the idea does not solve a problem or move the quality of life farther, there are many more things to be invented.”
With ever-changing market trends, the impact on drug legislation and regulations is inevitable and will differ from country to country. This means that pharmaceutical companies need to be more flexible and improve agility within their workforce to better understand the relevant legislation that they will be affected by.
Not only is changing legislation a challenge for the life sciences industry, but demand for industry solutions on issues including ageing populations, life-threatening diseases, expansion into emerging markets, and the development of treatments and technology all require an effective response. This will possibly bring further regulatory and legislative changes. In order to respond effectively, pharmaceutical companies need to hire the right professionals to adapt processes accordingly and ensure a successful outcome for projects. For example, it can take up to 15 years to develop and launch a new product, plus many problems may arise in the process, therefore the right strategy needs to be applied from the outset.
Moving the industry forward
Regulatory affairs professionals are becoming even more important to the life sciences industry, as their roles are becoming more involved in the development, manufacturing and bringing much needed medicines to the patient.
Regulatory Affairs professionals can play a key role in guiding drug development strategy in an increasingly global environment, where science is constantly evolving. Due to constantly increasing regulatory obligations and new requirements, as well as the globalisation of the pharmaceutical market, the demands and responsibilities of regulatory departments is becoming more and more complex.
Regulatory Affairs professionals help the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions are also placed upon the claims which can be made for the product on labelling or in advertising. Working closely with a recruitment company could help pharmaceutical companies become more flexible and innovative through the hiring of regulatory affairs professionals for every step of the product’s life.
How we can help
Recruitment companies can help finding candidates with the “right-first-time” approach which would then help to maximise the cost-effective use of the company’s resources. To help clients, Hydrogen is utilising its long-standing global network of experienced Regulatory Affairs professionals. Hydrogen can help global pharmaceutical companies to source Regulatory Affairs professionals who are not only experts in their respective field, but understand Global markets.
By hiring efficient regulatory affair professionals, pharmaceutical companies will then be able to demonstrate that they have active compliance programs across the business and that they can be ahead of their market, by bringing patients the much needed new and innovative medicines quicker and more efficiently than anyone else. It will also help avoiding unknown mistakes which can slow down the production process.
It is no surprise that one of the major challenges for life sciences companies is how to productively turn innovation into commercial products. Those organisations that are able to understand and adapt to reform’s challenges and opportunities are likely to be the leaders in the coming years. Regulatory affairs professionals could be the solution to help pharmaceutical companies to become more flexible and more cost efficient. If companies are not addressing the problem, this could push them to over-pay for skills they do not need on a project by project basis. Having more and more Regulatory affairs professionals could also help companies developing life threatening cure such as diseases related to population ages or life-threatening.
We’ll be exhibiting at this year's TOPRA, in Berlin, so visit our stand to discuss how Hydrogen can help your company or email Nikolay Dimitrov.