December 10, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Johnson & Johnson has created a new regulatory leadership program dubbed AcceleRAte to help groom its regulatory employees become executives in an increasingly regulated biotech ecosystem, the company told the Regulatory Affairs Professionals Society this week.
The society said that the amount of time regulatory professionals spend on management-related duties and business affairs “has risen sharply at all job levels,” according to its internal Scope of Practice & Compensation Study.
That has left larger companies to find ways to make sure they have members of their C-level suite who know exactly how to toe the line as the firm grows.
“We are dealing with both evolution and revolution. The healthcare regulatory environment continues to evolve as laws, guidances and global markets become more interconnected and technologies challenge existing thinking,” said Amy Smith, worldwide director of regulatory affairs for J&J’s Advanced Sterilization Products, and a sponsor of the program.
“What is revolutionary is the role [regulatory affairs] plays in overcoming these challenges and driving the business. We’re not just at the table; we have the responsibility to be a strong influential voice there,” she said.
The program was historically known as J&J’s Regulatory Affairs Leadership Development Program, or RALDP, but has morphed into AcceleRAte as the company began to look internally for top regulatory talent to promote to the executive level. Now the two-year rotational program has a specific mandate.
“[It will] bring in high-potential professionals from outside J&J, and give them training and experience in a variety of the company’s medical device and diagnostics (MD&D) business units, as well as business and leadership training, and access to top company executives,” reported RAPS.
Johnson & Johnson officials said they believed the program had distinct advantages for the company, particularly as the changing landscape for corporate America as included a patchwork of rules and regulations only a professional can understand.
“It used to be that all a regulatory associate did was submissions, following the strategy created by the business leaders. Now, changes in the regulatory environment have required us as regulatory professionals to become not just involved, but leaders in creating the regulatory strategy for the business,” said Raina Dauria, vice president of regulatory affairs for J&J’s Ethicon Biosurgery unit and one of the program’s key partners. “The success of medical products is directly related to the regulatory environment, and the regulatory professional has become critical at the executive board table.
Johnson & Johnson had created an entire set of internal literature to outline what—and where—it hopes AcceleRAte will take both the company and the employees it mentors via the program. Dauria said that J&J has gotten with the times and undergone a “significant culture shift” as a result.
“Ten years ago, Regulatory Affairs was not perceived as a critical core member of the product development and commercialization teams across the medical products industry. Today, it is a very different landscape: RA is seen as an essential driver in J&J’s success in the US and abroad, and the conversations have changed from ‘Why are they here?’ to ‘Where is RA?’,” said the handbook. “We’ve worked with them and they have really made a difference.”
