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Regulatory Affairs is a key hub in any life science company whether they are Pharma, Biotech or Medical Devices. It interacts with all key areas in Research & Development, Commercial and Regulatory Authorities throughout the World. These regulatory jobs can be Global, Regional or National in nature.
There are some key centralised regulatory jobs such as Regulatory Policy, Regulatory Submissions Operations and Regulatory Labelling where attention to detail, time management and project management skills are critical. However, roles are generally partitioned into the key areas of Regulatory Development and Life Cycle management / post-marketing and the roles and skill sets required in these areas can be quite distinct:
The influence that Regulatory Affairs has had on the development of a Company’s global clinical development plan has increased dramatically in the last few years, as companies seek to ensure products are brought to market in the most optimal time frame. These regulatory decisions need to be taken early in the drug development process and the Regulatory team are the key interface with the Regulatory Authorities when it comes to taking Scientific Advice with the EMA, FDA or National Authorities. The Emerging Markets, especially China, Korea and India, are also impacting upon Global regulatory development plans. The ultimate aim is to take products through the clinical development process to gain marketing authorisation (MAA), demanding the recruitment of employees with the right balance of scientific knowledge, project management and communication skills.
Regulatory Lifecycle Management
Once a product has gained marketing authorisation, different skill sets are required as the focus turns towards compliance, change control, and ensuring that the promotional activity is in line with the product labelling. Candidates therefore need a good commercial outlook in addition to the project management and communication skills that are generally required in Regulatory Affairs.
Liftstream have an in-depth knowledge of regulatory careers and regulatory recruitment and have developed a leading reputation for recruiting transformational teams and individuals in the regulatory affairs area.