Welcome to my first posting for the RIMtelligence blog. As this is number one, let’s start at the beginning. Once upon a time, the regulatory function was not particularly well-defined and seemed to be more focussed on pagination than content. Are they Scientists? Medical Writers? Lawyers? Programme Managers? The answer of course is, all of the above and then some!
Throughout my professional career, I have enthusiastically witnessed an incredible transformation in regulatory affairs roles and responsibilities. No longer are we relegated to hole punching, paper copying and ink stamping. Technological and innovative advances in the Life Sciences field have enabled the industry to produce pharmaceutical cures, medical device software apps and gene spliced biologics. As the manufacture and testing of drugs, devices and biologics become more complex, the inherent risks increase. Mitigation of the risks are paramount for the patients and healthcare professionals. One method to support this important risk mitigation process is via health authority legislation. We, as regulatory professionals, are tasked to support the development and continued maintenance of these life changing interventions in an ever-evolving global regulatory environment.
Regulatory affairs teams of the 2000’s have a greater strategic role to play. We are no longer the closed door to innovation but a supportive guide through the quagmire of the guidances, acts and directives. We have progressed from liaison to diplomat, from undermined to subject matter expert and from following SOPs to leading strategic initiatives. The requirements of the regulatory skill set now includes an increased communication aptitude both internally (cross-functional teams) and externally (health authorities). Computer programmes have increased efficiency for medical writing, document publishing and data storage, requiring another specialised competence. Regulatory teams are constantly challenged to obtain approvals faster for which we wear multiple hats. Many companies have added a regulatory responsible member to their executive committees thus recognising the importance of the role. We are now a vital team member in the innovation funnel, from concept to discontinuation.
Our various regulatory roles (assistant, specialist, project manager, operations, intelligence etc.) come with great responsibility. I look forward to discussing a wide range of topics and some of the challenges faced when performing our day-to-day tasks. Please feel free to drop me a note if you would like to comment, discuss a topic that is close to you or even rant about an unforeseen challenge.
Thank you for reading and I look forward to further engagement.