Over the past decade, life sciences companies have increasingly realized that regulatory expertise is a mission-critical business asset. The amount of time regulatory professionals spend on business and management-related duties has risen sharply at all job levels, according to RAPS’ own Scope of Practice & Compensation Study.
Some, more forward-thinking companies are taking this a step further, actively grooming regulatory professionals to be business leaders and creating new paths for them into company C-suites. Among them is one of the largest, most well-known organizations in the healthcare sector, Johnson & Johnson (J&J), which has embraced the concept in a big way.
“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. 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,” says Amy Smith, worldwide director of regulatory affairs for J&J’s Advanced Sterilization Products, and a sponsor of the company’s “AcceleRAte” regulatory leadership development program.
Originally called the Regulatory Affairs Leadership Development Program, or RALDP, the program was launched in 2013 and is geared toward recent master’s graduates and other talented professionals looking to make the transition into regulatory.
The idea for the AcceleRAte program came from Minnie Baylor-Henry, J&J’s worldwide vice president, regulatory affairs for the medical devices and diagnostics (MD&D) sector. Baylor-Henry is passionate about talent development and leads the company’s Regulatory Affairs Council, which is responsible for regulatory talent across all MD&D companies. Over the last several years, she has overseen an effort among senior leaders within the council to take a hard look at the pipeline of regulatory talent.
While these senior leaders believe J&J has a strong upper-level leadership pipeline and solid technical leadership at more junior levels, they were not satisfied with the development system for the company’s mid-level regulatory talent. This gap would need to be filled to ensure the quality of future senior leadership in the regulatory function.
They decided to create the two-year rotational program to bring in high-potential professionals from outside J&J, and give them training and experience in a variety of the company’s MD&D business units, as well as business and leadership training, and access to top company executives.
A Culture That Values Regulatory Leadership
“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. The success of medical products is directly related to the regulatory environment, and the regulatory professional has become critical at the executive board table,” says Raina Dauria, vice president of regulatory affairs for J&J’s Ethicon Biosurgery unit and one of the program’s key partners.
J&J’s internal literature on AcceleRAte puts it this way: “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?’ We’ve worked with them and they have really made a difference.” According to Dauria, J&J has undergone a significant culture shift, placing increased emphasis on developing global, key business leaders from the regulatory talent pool.
This initiative is no minor pet project. It is being driven by top executives at the enterprise (company-wide) level, including those who oversee entire global groups of J&J’s business units. These company decision-makers understand they need leaders with regulatory expertise—leaders who have the capabilities to track trends, anticipate critical regulatory landscape changes, leverage opportunities to interact with regulators and address challenges, all within the context of successful business strategy execution. Regulatory leaders must be able to work across project teams and functional groups, and articulate to internal and external stakeholders at all levels the regulatory issues that need to be addressed and why. AcceleRAte is designed to create a robust pipeline of regulatory professionals with these capabilities that will be poised to impact J&J’s businesses over the next five to 10 years.
Developing a Well-Rounded Skills Toolbox
Over the course of the two-year program, AcceleRAte participants are given two to three assignments, each lasting from eight to 12 months, within various MD&D business units—in some cases in different locations around the world. They also engage in classroom and online training in leadership, business and other professional skills, including several “leadership challenges” throughout the program. Currently, there are 19 participants. The first class of participants will enter their final rotations in January 2015 and graduate in September of that year. The rotational assignments are determined individually, but the skills these professionals learn are applicable to a variety of global business settings and situations, and they have to pick things up quickly. “Learning happens at an accelerated pace,” says Dauria.
All participants are expected to sharpen the technical regulatory skills they need in their day-to-day work, but throughout the program, they also get what Dauria calls “a well-rounded toolbox” of business and soft skills. Emphasis is placed on how to influence regardless of position within the company. “We are not all VPs, and we must learn to lead without relying on a title or authority,” said Dauria. “Every person at J&J is considered a leader. It’s part of our competency model. It’s part of our global HR imperative. The expectation is that people are going to lead within their current roles to add value to their projects regardless of their level.”
Seeing the Big Picture
Dauria also emphasizes the importance of “line of sight to the larger business,” noting that leaders at all levels must understand how each part of the company affects the business. “If they’re going to be future leaders, they need to understand how the entire business works, not just their company or sector, but across the entire enterprise,” she says. Participants seem to get that, and appreciate the opportunity to see the big picture through the eyes of the company’s current leaders. AcceleRAte program participant Elizabeth Jacobs, who works in J&J’s Vistakon unit, says participation “provides opportunities that I normally wouldn’t experience at this level and gives me the ability to connect with senior leaders across MD&D.”
Support From Senior Executives, Peers
This access to, and support from, senior J&J executives may be one of the keys determining the program’s success. Senior leaders at the company’s highest levels have enthusiastically backed AcceleRAte—not just with rhetoric, but with budget dollars and with their own valuable time. Todd Kerestes, a class member with Ethicon USA, praises J&J’s senior leaders for their involvement and encouragement. “They expressed commitment to us and the program and how important we are to the future of J&J’s Regulatory Affairs function,” he says.
But networking with J&J executives is not the only benefit of being among this select group of up-and-comers. Lynn Pawelski, vice president of regulatory affairs, global surgery and energy at Ethicon, contends, “One of the most valuable components of the AcceleRAte program is the dynamic exchange of ideas. Participants are not only learning who they want to emulate and how they want to lead, they are also bringing a fresh perspective and ‘generational’ thinking to the company.”
The chance to learn from peers is a big plus for AcceleRAte participant Chad Mazurek, a class member within Mentor Worldwide. “We gain tremendous collective knowledge by sharing our experiences with one another, and by being exposed on a regular basis to smart people with many different viewpoints and focuses,” he says.
Global Perspective, Personalized Opportunities
The program’s global rotational model fits J&J and its various business units well because the corporation is made up of more than 275 operating companies in 60 countries worldwide. This allows the AcceleRAte program to offer participants a variety of experiences across the globe, within different business units, and now, even across sectors. In a recent addition to the program, new class members are able to participate in a rotation within the pharma sector, with J&J’s Janssen Pharmaceuticals unit.
The opportunity to work in a variety of settings around the world is a valuable part of the program. Chenguang (Sean) Zhao, a participant within Vision Care who began the program working in the US, and will rotate to China in 2015, appreciates the chance to become familiar with more than one regulatory system, commenting that “the differences in regulations and laws between the United States and other countries become very clear.”
While the AcceleRAte experience is designed to offer global opportunities and perspective, program managers also have learned to be adaptable to specific situations. Some employees may work in settings where it is not possible to rotate to different units around the world. For example, Vistakon, where Jacobs works, is the only J&J company in the southeastern US. So AcceleRate sponsors and the program manager have worked to create other cross-functional assignments within Vistakon. Company executives say this flexibility has been critical to the success and support of different MD&D businesses within J&J.
A Model for Regulatory Leadership Development?
While J&J is a large company with considerable resources, approaches like the one used at Vistakon could serve as a model for smaller companies to emulate. “I think there are opportunities in smaller companies, it’s just a matter of being flexible,” says Dauria. Her advice to others seeking to develop healthy regulatory talent pipelines? “Be courageous. Give chances to people in whom you see potential; then support them in taking risks while giving them the space to learn and grow. Give people a chance to show they can do it. Don’t be afraid to let go a little bit while making sure you’re not setting anyone up to fail.”
The Future of AcceleRAte
If AcceleRAte proves successful, it could benefit J&J not only with an internal cadre of highly competent regulatory leaders, but also with a very compelling recruiting and retention proposition. It’s built to be attractive to high-level talent. Dauria says she and other program sponsors are looking at extending the program to current J&J employees in the future, but whether the candidates for the program come from inside or outside the company, the ultimate goal is the same—to blaze a new trail for the company’s next generation of regulatory business leaders.