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A Modest (Regulatory Affairs) Proposal

September 29, 2014

Siting in a session on the strategic value of Regulatory Affairs to THE BUSINESS, it became clear to me that we needed a complete paradigm shift if we had any hope of getting all of this right. Both sides of the equation (regulatory and the business) are so entrenched in their own perspectives that they’re each unable to raise up the level of discourse and approach regulatory as a strategic part of the life sciences value chain.

With that in mind, I wanted to make a modest proposal, which might be as poorly received as Swift’s was almost 300 years ago…but here goes.

Imagine what our life sciences organizations would look like if, as a part of business as usual, we rotated regulatory resources through the key business functions, from R&D, through manufacturing and quality, to commercial/sales, medical affairs, etc., and assumed that deep business knowledge was as important as regulatory domain knowledge for their success.

The result, I think, would be Regulatory Affairs professionals who viewed their work through the lens of do this so we make more money as an organization rather than the lens of do this or else (and we’re okay being a cost center/administrative overhead).

And it’s not like this idea is science fiction. I sat in a presentation today where folks shared that they participated in professional development programs similar to this one at real life organizations. But these are the exception that proves the rule. Most life sciences organizations don’t have such a program in place–RA is a backwater cut off from the business and trapped in being considered a cost center.

So what I think is needed is to adopt an industry standard pathway for RA professionals that exposes them directly to every stage in the product development lifecycle at a life sciences organization, which would kill two birds with one stone.

First it would ensure that RA professionals understood the context of their work and wouldn’t do regulatory for its own sake, but rather to achieve tangible business goals.

Second it would help the business understand RA by giving them broad exposure not only to RA professionals but to the complex work RA does day in and day out to get products out the door in life sciences orgs.

In the end, such a program would give an organization strong competitive advantage over its peers, because the ability to bring complex products to market globally in a diverse compliance environment is a tremendous leg up over the competition.

The Final Word

It’ll take more than a single blog post to get organizations to adopt a new RA paradigm, but hopefully the change in attitudes and approaches I saw today at RAPS signals a sea change in how life sciences organizations are going to approach RA going forward. In the meantime, I’d love to hear from my RA compadres out there about how there organizations are approaching RA–jump in, and let’s get the conversation started!

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