The Missing Piece: Adding Regulatory Affairs to Employee Onboarding
Throughout my career, I’ve made it a priority to integrate Regulatory Affairs (RA) into the onboarding programs of every company I’ve worked with. The basis for this passion is my belief that when the wider business understands RA’s role, our job becomes easier and fewer issues arise.
The Current State of Onboarding
A typical pharmaceutical onboarding programme will concentrate on mandatory Quality and Pharmacovigilance training, HR essentials, company policies, and role-specific training. My recent LinkedIn poll revealed that only 50% of companies include an overview of RA – slightly higher than I expected, but a clear indicator there is significant room for improvement.
The reason this gap exists is likely due to time constraints, perceived complexity and well, if you don’t understand Regulatory yourself, then you won’t see the relevance of including it.
This gap differs from the challenge of departments that fail to involve us early enough, despite understanding our role – that’s a separate blog waiting to happen! Instead, I’m addressing roles that don’t routinely interact with RA.
The cost of ignorance
A pharmaceutical company operates like an ecosystem, where all departments are interconnected and the actions of each will impact the others, either directly or indirectly. Understanding the roles of functions you may not directly collaborate with is paramount for business success.
When teams don’t understand the RA’s role, the consequences include missed opportunities and potential non-compliance. Here are real examples from my experience:
- Sales targets set for product launches six months before regulatory approval was due
- Manufacturing changes to Master Batch Records that conflicted with approved dossiers
- Direct contact with the MHRA asking if non-compliant batches could be released
- Cancelled payments to Health Authorities, causing assessment delays and validation issues
- Inappropriate assignment of change control and deviation actions to RA simply because changes “involved a license”
While these issues may also be a result of communication breakdown and system failures, it’s reasonable to suggest that many responsible parties had no understanding of RA’s function. The result? Wasted time, damaged reputation, non-compliance and risk to patient safety.
Don’t leave room for mistakes or assumptions about what RA does.
The 30-Minute Solution
Including a quick overview session in your company onboarding programme is a good place to start! It doesn’t need to be lengthy or tedious, the key is making it engaging by demystify the complexities.
Making It Work
If your company onboarding programme lacks information on RA, you need to take ownership of elevating awareness and educating colleagues by taking the following step…
- Engage the onboarding team – highlight the need, risk and benefit
- Inform your manager – as it will require a small time commitment
- Request our FREE presentation – click here to download a copy of our ‘Introduction to Regulatory Affairs’ slides to use as a foundation for your own company content.
Don’t stop there, if RA has been missed in your onboarding programme, there are likely to be more opportunities to increase awareness:
- Run a series of intro to RA presentations to colleagues who have already missed the opportunity to learn
- Add RA insights when answering routine queries
- Present case studies of project successes during company wide meetings
If you need support creating a bespoke onboarding presentation tailored to your company’s specific needs, contact us to discuss how we can support you – as we love talking about Regulatory Affairs!!
