Leading the Way in Product Safety
Our lives intersect with the world of regulatory affairs multiple times a day, yet many don’t quite understand how the field keeps them healthy and safe. That’s likely because regulatory affairs leaders are intelligent, dedicated, and passionate individuals that make the process invisible to consumers, as it should be.
Regulatory affairs focuses on the safe advancement and commercialization of the pharmaceuticals that keep us healthy, the quality of the food we eat, the care we give our pets, and even the cosmetic products that are part of our personal care routines. Lately, the most visible example of regulatory affairs is the rapid development of COVID-19 vaccines and the global drive to vaccinate the 7.8 billion citizens of the world. The pace of innovation is speeding up, and regulatory professionals ensure that progress and safety go hand-in-hand.
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More than 330,000 FDA-registered facilities are involved in the production of biologics, pharmaceuticals, food, medical devices, and animal food and drugs. Each of these entities is regulated, and they have a leader responsible for the process—increasingly, that person carries the title of Chief Regulatory Officer.
What Does a Chief Regulatory Officer Do?
Like many jobs in regulatory affairs, titles vary greatly. While many companies designate the top position as Chief Regulatory Officer, it’s just as standard for the role to be assigned as a Vice President, Head of Regulatory Affairs, or Chief Compliance Officer. According to Jennifer Scalise, lecturer in Northeastern University’s College of Professional Studies, “Whatever the job title, the role and its responsibilities are essentially the same. They help their business succeed by ensuring solid regulatory practices and strategies. They’re responsible for ensuring products go from concept to commercialization with full compliance, consistent processes, and clear documentation to ensure that they’re safe.” The emergence of “chief regulatory officer” as a respected title demonstrates the value of regulatory affairs teams. It acknowledges that a company’s viability and its products live or die based on proper safety protocols.
Primary Responsibilities of a Chief Regulatory Officer
A job description for the top regulatory position will fluctuate based on the type of company, size, and available resources. Scalise says, “The lead regulatory person should be involved from the beginning to the end of every project—ensuring that a strategy is in place that is consistent with established processes, controls, and documentation.”
Chief regulatory officers typically perform the following duties:
- Oversee compliance within their organization, and ensure full compliance with laws, regulatory requirements, policies, and procedures
- Ensure that the company has a deep commitment to providing up-to-date knowledge of regulatory compliance throughout the organization by providing ongoing training
- Be the first and last voice on all regulatory matters, providing clear strategic direction for senior leadership
- Develop, monitor, and update an annual compliance plan that addresses the specifics of the company’s activities and products
- Consistently stay ahead of regulatory and legislative changes that impact the organization and its relationship with regulators
- Be a partner in the development of product marketing concepts and approve relevant packaging and advertising
- Lead compliance teams and monitor the success of staff and programs
- Monitor internal audits and compliance reviews, investigating matters as needed
- Provide the board of directors with detailed compliance reports and inform them about important issues and material violations
- Act as most senior contact for regulators and ensure audits, reviews, and examinations are consistent and accurate
- Foster an environment that encourages employees at all levels to report issues, improprieties, and concerns that could harm the public and undermine the company
Skills of a Successful Chief Regulatory Officer: What it Takes to Lead
The top regulatory job requires an extensive skill set—but depending on the industry, company, and larger team’s strengths, those skills will differ.
“If I were hiring somebody in regulatory affairs, I would want someone with excellent organizational skills and ideally experience in quality control. Another plus would be solid writing skills and the ability to articulate scientific or legal processes,” Scalise says. “For the top position, companies look for leadership with either a legal or clinical background. They also gravitate toward individuals that are active in regulatory industry conferences and organizations and are well-versed in compliance standards.”
The emphasis on a legal background is not surprising; it’s essential to the job. Scalise says, “when you have directives and guidance issued from the government, it’s more than a suggestion. Companies need leaders that can read and interpret guidelines, laws, and changing regulations—and turn them into company practices.”
According to Scalise, “A successful chief regulatory officer is a stakeholder in the business. Things are not always black and white, or yes or no. You need to be a respected business partner who knows the consumer’s best interests are the company’s best interests. You also can’t be completely risk-averse. While risk is inherent in the process, a good regulatory leader can’t be an alarmist, or they risk losing credibility.”
Some other leadership skills that Scalise ranks highly:
Agility: No two days are the same. As such, the nature of the job demands flexibility. Circumstances can change quickly, and a wise chief regulatory officer anticipates and reacts to the variables inherent in the development, approval, and production process.
Relationship building: The success of a regulatory lead hinges on their ability to build relationships with both internal partners and regulators. Trust is earned and built over time. A regulatory leader without credibility and integrity will damage a company over time.
Negotiation: Much of a chief regulatory officer’s work is nuanced as the job requires translating regulations into actionable steps for the company—and ensuring that translation and execution meet the needs of regulators. Not all translations are absolute.
Reliability: A successful regulatory lead should have a reputation with their regulators for meeting or exceeding expectations and requirements.
Obstacles and Challenges
An effective chief regulatory officer needs to be a culture influencer. They must have a seat at the table, and sometimes earning that seat takes time. Scalise says, “companies can hire the most experienced and talented people to run regulatory affairs, but if other department heads don’t listen to them and accept their input, you’re not going to have a successful company. Teamwork is more than a slogan in regulated industries—it’s an absolute,” Scalise adds. “To get a drug on the market and keep it there, you have to listen and partner with the right people at every part of the process.”
Audits are another challenge. They’re part of the job and can be announced or unannounced. Inexperienced companies without the right personnel in place are vulnerable, as regulators are looking for consistently thorough compliance—and it’s their job to be sure companies are meeting requirements. Scalise says, “I always tell my students that cookie-cutter approaches are not going to work. If your processes for different products are the same, then those products are likely not safe for consumption.”
Regulatory Jobs on the Rise
As the field continues to grow, working in regulatory affairs will remain a solid career choice. In 2019, the value of the regulatory affairs market was nearly $11 billion. In the next seven years, compound growth is estimated at 8.4 percent annually. As regulated industries innovate faster, the need for qualified applicants to fill senior positions will be more intense. Scalise says, “The development of COVID-19 vaccines showed the entire world how quickly things could move forward. This expectation will likely put more pressure on drug companies to try and get fast track approvals.”
Learn More: The Drivers of Regulatory Affairs Growth
How to Prepare for a Career in Regulatory Affairs
While most regulatory affairs professionals come from the sciences, many succeed in the field with other backgrounds, including legal and marketing. An advanced degree opens more doors, and leading degree programs are highly competitive.
As a lecturer in Northeastern University’s Master of Science in Regulatory Affairs program, Scalise sees students of differing backgrounds thrive in the program and graduate with evolved interests and skills. Scalise says, “I love that my students represent a range of disciplines. Some have majored in science or pharmacy. Others have a law degree. They are all great candidates to rise as leaders. Combining a master’s degree in regulatory affairs and a few years of experience in the field demonstrating leadership potential bodes well for future success. It’s also exciting to see students grow throughout the program. Based on the insights and experiences gained while they earn their degree, many students graduate with a focus very different from their starting place.”
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