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What does a Content Management Technology Search and Consulting firm know about placing Regulatory Affairs Pros? If you're asking yourself this question, we're not surprised! We asked it of ourselves in 1995 when both the Chief Information Officer and the Vice President of Regulatory Affairs of a pharmaceutical research institute asked us to conduct a search for the cross-disciplinary team that would deliver its first electronically published New Drug Application (NDA) to the FDA.
"We're early adapters and the success of our initiative," the VP of Regulatory explained, "is dependent not only on the technology that the people you've already placed with us will be implementing, but also on how well it is mapped to our processes and on whether or not our authors and publishers embrace the workflows that will allow us to create an FDA compliant submission in record time."
"What we're saying," the CIO chimed in, "is that we need the same kind of intelligence, enthusiasm, and expertise in Regulatory and Regulatory Ops as you gave us in IT."
"But we don't...," we began to say, but the CIO cut us off. "You do know how to find good people don't you?"
"If we're going to do this," we said, "We're going to have to do a great deal of learning before we can even identify them."
"We'll help you do the learning," said the Regulatory VP, "if you promise to mine until you find gems. There's a market here for you, you know. Look, you've found your first client before you've even created any collateral."
We haven't stopped learning or mining since then. We've listened to customers, candidates and Regulatory Publishing vendors talk to us about input sources and output options, complex information components, document definitions and data standards, NDA's , ANDA's, IND's, BLA's , sNDA's and sBLA's and so on.
Shortly after our IT customers taught us about XML, we began to hear our Regulatory customers talk about harmoni(s)zation, Common Technical Documents (CTD's), eCTD's, SPL and PMI- and we actually understood how technology enabled business and changed processes once the FDA approved.
So going back to the original question, What does a Content Management Technology Search and Consulting firm know about placing Regulatory Affairs Pros? If you're talking about BrilliantLeap, the answer is quite a lot. We’ve worked long and hard to get to know the people who manage, participate in and enable the processes that help our clients get their products to market both safely and in record time.
Whether you're a LifeSciences, BioTechnology or Medical Technology firm looking for Tier One Regulatory Operations, Regulatory Affairs, or Regulatory Submissions professionals or a leading Regulatory professional seeking an employer or assignment that leverages your experience, contact us.
Pairing brilliant people with the organizations prepared to leverage their knowledge is what we're all about.
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