Susan Carino’s face still breaks into a wide smile as she describes achieving her Regulatory Affairs Certification (RAC).
“The proudest moment for me was attending Regulatory Convergence and seeing my name on the list of those who had passed the RAC exam. That was very special,” said Carino, a regulatory project manager in the Bay Area. “RAPS celebrates those who pass the RAC at Regulatory Convergence—and there are some who have multiple RAC certifications. Maybe someday I’ll be one of them.”
Forty years ago, RAPS was born as members of a burgeoning profession desired to keep abreast of regulatory developments in the medical device industry. As the scope of work of regulatory professionals has expanded, so too has RAPS’ mission to drive regulatory excellence for the profession, paving the way with training and certification.
“The ‘RAC’ at the end of your name demonstrates that you have the interest and capacity to learn the foundations of the profession,” said RAPS Board Member and Interim Strategy Lead Don Boyer. “It is a tough but broad exam that attests to your capacity to learn about the statutory instruments, the regulations and the guidelines associated with a variety of products.”
“RAPS really helped develop the regulatory profession by creating an RAC certification that people can reference as a foundation of their knowledge,” said RAPS Board Member Glenn Byrd.
RAPS member, Meredith Brown-Tuttle, calls the education and training offered by RAPS essential. “If you are ready to learn and absorb what RAPS has to teach you, it is mission critical to your growth, your performance and your career,” she said. “The RAC, in particular, says to the profession that you understand the depth and breadth of what it means to be a regulatory professional.”
Many RAPS members point to the RAC and its certification as being an instrumental part of their career success. “Preparing for the RAC exam provided me an opportunity to learn not only about the medical device industry, but also about pharmaceuticals, biologics and other regulated industries—and about the history of regulation,” said RAPS member Anjali Atal-Gupta.
“The RAC shows you are passionate for regulatory and took the extra effort to get the credential. Employers generally are impressed with professional development initiatives,” added Pooja Shah, education chair for the Bay Area Chapter.
Carino, too, feels the RAC exam contributed to her career. “As a professional project manager, clients want to see authentic credentials. I have certification in project management, as well as certification in regulatory affairs. It’s fairly unique in the industry and clients really admire that,” she said.
As the regulatory profession continues to grow, RAPS strives to continue its role as the premier global provider of professional development offerings to sustain a prepared, competent and connected global regulatory profession that drives sound regulatory practice and policy to advance public health.
For many, the profession is about continual learning and integrating new findings in the areas of science, technology, policy and business. “The required skills have changed over the course of my career,” said Shaalini Doan, head of the Bay Area Chapter. “You must work cross functionally and be able to communicate well. One must have the regulatory background—sometimes globally—and be able to incorporate that knowledge into a launch strategy in multiple markets.”
“There is such specialization in the profession today, given the diversity of products and complexity of regulatory definitions,” said Boyer. “All of this has required our organization to evolve and offer the education our members require in order to stay abreast of the latest developments.”
“RAPS offers a vast amount of training opportunities such as RAPS Online University, which is a good place to learn competencies early in your career,” explained Linda Bowen, chair of the RAPS New York/New Jersey Chapter. “The RAC, local volunteer and networking opportunities, as well as those at Regulatory Convergence, are also available for those who want to advance as regulatory professionals.”
“What RAPS offers adds to the credibility of the profession no matter the part of the world that you come from,” points out Boyer. “RAPS got its start in the US, but now RAPS is on a mission to take this profession global. The RAPS certification and its trainings are becoming more and more popular—and important—for regulatory professionals from around the world.”
This article is one in a series looking at the development of the regulatory profession and of RAPS during RAPS’ 40-year history. This year marks the organization’s 40th anniversary, which will be celebrated during the Regulatory Convergence, 17–20 September in San Jose. For more information or to register, visit RAPS.org/Convergence.
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