What Is The Strategic Importance of Regulatory Affairs?
Due to the ever changing regulatory environment, the increase of requirements, the increase of development time and cost, and the commercial pressures that are threatening pharma success are just a handful of reasons that RA strategy is so important.
There is a high demand for truly qualified Regulatory Affairs professionals and for RA Strategy. RA has, thus far, played a significant role throughout the healthcare product cycle. This includes every stage of development such as market and post-market supervision of medical drugs, biotech products, medical treatments, development, medical devices, and distribution.
In this area we have seen an increase in the number of graduates with business degrees and those with executive education due to the fact that there are many times when those professionals will need to engage in important business functions.
The need to understand and participate in corporate and organizational strategy, Health tech assessments, government affairs, legal issues, and comparative research are paramount within this profession.
In this profession many of these professionals are in touch with a vast amount of regulatory systems across the globe. More than half of respondents work multi-regionally or globally. The products of the healthcare sector are more global today than they ever have been before. As well, the regulatory environment is more detailed and requires a very special level of expertise and skill.
The Role of RA?
In the Corporate and Central sectors of this profession we see a large area that is needed in regards to a skill set.
Construction of the core dossier
Global regulatory strategies
Full involvement in the developmental process
Diligence with RI
Vigilance in pharma
Central labeling profile
Worldwide business development
In the areas of Local and Regional:
Region specific data
Local RA strategies
Development of local businesses
What Is Regulatory Strategy?
Regulatory strategy is addressing developmental issues, planning regulatory affairs, registering a product within the global market, and balancing cost, time, and resources.
The conclusion is simple. RA is a critical and integral part of every pharma business. It requires sets of hard and soft skills and demands continuous professional development. This profession requires adaptability and flexibility so that you’re prepared for any sudden changes. An RA professional is a much needed and essential part of the pharma industry.