A quick regulatory affairs career guide, with advice and resources for beginners, leaders, and everyone in between
Regulatory affairs professionals play a pivotal role in ensuring healthcare products are both safe and effective, while guiding companies through the complex landscape of regulations imposed by global regulatory authorities.
The work of a regulatory professional not only safeguards public health but also enables companies to bring innovative medical devices, pharmaceuticals, biologics, diagnostics, and other healthcare products to patients around the world.
The day-to-day life of working in regulatory affairs will vary depending on role, sector, employer and career stage, and other factors.
This guide will show you common pathways into the regulatory profession, job titles and job responsibilities for regulatory professionals, and ways to advance in the regulatory field and improve your skills during your career.
» What is regulatory affairs?
Regulatory professionals ensure compliance with regulations from health authorities to support the development of safe and effective healthcare products. A career in regulatory affairs can take several different paths. A few factors that will determine your regulatory career direction include the product sectors you work in, the types of companies you work for, and the geographic region you work in.
Large organizations may have large regulatory teams, while the regulatory team at a small organization may consist of a few people or just one person. Many regulatory professionals do not work for the companies who make healthcare products and instead work as consultants who help those companies. Regulatory often overlaps with quality, as both professions require following standards.
Regulatory professionals work most commonly with pharmaceuticals and/or biologics and medical devices.
The broad spectrum of regulatory affairs jobs means you are unlikely to have a role that encompasses all elements of the regulatory profession, especially at your first position.
This list is a sampling of the many roles regulatory professionals play in getting safe and effective products to market.
- Aiding organizations in the accurate presentation of scientific thinking and data
- Counseling organizations on scientific requirements and restrictions
- Providing technical and strategic advice
- Establishing processes for commercial and scientific success
- Maintaining regional, state, national and global compliance
- Acting as a bridge between organizations and regulatory authorities
- Creating regulatory submissions for health authorities such as the US Food and Drug Administration (FDA) or European Medicines Agency (EMA)
- Developing monitoring solutions related to product safety concerns
- Tracking changing regulations and assessing their impact to organizations and industry
- Communicating with regulatory agencies to stay current and negotiate plans
- Identifying and mitigating regulatory risks
» How to get into regulatory affairs
A career in regulatory affairs is an opportunity to contribute to the health and well-being of humanity.
But navigating global healthcare regulations is also a chance to exercise skills and knowledge areas that span many domains, with room for technical-focused roles and roles that require a heavy dose of patience and teamwork. Plus, as recognition of the valuable role of regulatory professionals increases, so does compensation for regulatory professionals.
Regulatory career tip: download our latest Global Compensation and Scope of Practice Report for information on compensation by regulatory job title and much more.
Download the RAPS Regulatory Competency Framework to see the essential elements of what is required of regulatory professionals at four key career and professional levels.
A regulatory affairs career is a chance to make a difference in global health
A career in regulatory affairs opens new doors and opportunities for individuals looking to make a real-world impact.
“It’s about making sure the products we use are safe for people and patients at the end,” says Grace Charles, senior regulatory affairs specialist at Saluda Medical and a RAPS member. “I think it’s important to have people in that space or who are on the patients’ side and want to make sure they are getting the care that they need.”
Regulatory is a varied profession full of career possibilities
“I stumbled into medtech regulatory many years ago, as a young physicist who needed a job near Montgomery County, MD,” says Jay Vaishnav, PhD, RAC-Devices, FRAPS, lead editor of From X-Rays to AI: Navigating US Regulations in Radiological Health. “I stayed because it was interesting. The validation of medical products can involve subtle scientific questions; questions about the questions; questions within questions. The answers feed into a complex landscape of innovation, engineering, business, communication, law, marketing, medicine, and public health.”
A regulatory career can surprise and challenge you, and that is true no matter what path you take. While you will often hear regulatory professionals say that no one day is the same as the rest, it is also more broadly true that one year is not the same as the next. As healthcare products constantly evolve, your career will too.
Regulatory affairs is a growing profession that is continually becoming more valued by companies worldwide
When regulatory affairs was in its infancy as a profession, healthcare companies often thought of regulatory requirements as a problem to be dealt with at the end of product development process.
Companies are now making progress toward embracing the reality that the earlier you bring regulatory into the process, the better your outcomes are likely to be.
Pro tip: A RAPS membership keeps you connected to a global community of regulatory professionals dedicated to helping each other learn and advance their careers.
» What should I expect from a career in regulatory affairs?
There is no one set path you must take to get a job in regulatory affairs. But there are a few common ways into the profession.
What degree do I need to get a job in regulatory affairs?
There is no specific degree program that is required to enter the regulatory profession, or that guarantees a job in the field. It is most common for regulatory professionals to come from backgrounds that include education and work experience in life sciences, engineering, or related disciplines.
But again, there is just no set requirement for someone interested in entering the regulatory field.
Similarly, while the majority of regulatory professionals do possess graduate degrees, that doesn’t mean a graduate degree is necessary to enter the profession.
As the regulatory field has grown, so has the number of regulatory degree and certificate programs. RAPS keeps a list of regulatory academic programs.
Pro tip: books like RAPS Fundamentals of Regulatory Affairs series and RAPS online courses and certificates can help you learn valuable regulatory knowledge to advance your career.
The most common path into regulatory starts in a related field
And while it is becoming more common to enter regulatory affairs right out of a university program, the most common path into regulatory affairs starts by working in a field adjacent to regulatory.
“Maybe you're already in biotech or at a med device company doing R&D, or something similar. If there's a regulatory team at your company, chances are your paths will cross at some point, whether you're in marketing or in the lab: regulatory permeates everything, and the team will have to work across the organization to help with a submission,” says Allison Komiyama, PhD, RAC-US, FRAPS. “That means there's an opportunity to get involved, learn, offer to help, and either shift over to that department or, with the added help of the resources outlined above, maybe move on to something else.”
But you don’t have to work at a big company in a related field to get into regulatory. Our profession is full of stories of people accidentally falling into the profession and discovering that it suits them.
» Leadership in regulatory affairs: how to advance in the profession
As you progress in your regulatory career, you will add skills to your toolbelt. By the time you’re a regulatory career veteran with 15-plus years of experience, your career will have likely gone through many changes.
One of those changes could be the transition from an individual contributor role into a leadership role that requires supervising a team.
“Regulatory leaders are highly accountable for both the public’s safety and the business, brand, and revenue. They may lead teams of a hundred or more professionals and have a long-lasting impact on the careers of many aspiring future leaders. In that context, technical skills alone do not make effective leaders. Effective regulatory leaders today are relying more than ever on skills from other functional areas (e.g., research and development, compliance, and marketing, among others) and on relationship skills they have developed over time with critical experiences. Today’s regulatory leadership needs to have a multifaceted skillset to distance itself from the norm.”
Citation Patel R, et al. The leadership role in regulatory affairs. RF Quarterly. 2023;3(3):31-37. Issue dated 30 September 2023
If you progress down a manager pathway, your day-to-day will not just be about regulatory submissions and regulatory activities. Instead, you may end up spending large parts of your time advocating for regulatory to the rest of your company and managing the regulatory employees who will have their heads down in regulatory-focused tasks.
If you end up on more of an individual contributor career pathway, as is more common at smaller companies or consultancies, your skills and day-to-day activities will evolve, becoming more sophisticated and refined. Alongside growth, your regulatory responsibilities and the impact of your work will also expand, allowing you to take on larger, more significant challenges.
Pro tip: learn valuable leadership and business lessons at the RAPS Kellogg Executive Development Program, or learn vital regulatory communication skills at our Advanced Strategic Communication Program.
Regulatory leaders need skills in communication and negotiation
Regulatory affairs professionals with years of experience often find themselves negotiating an issue with huge implications for the company’s future. When you are negotiating with health authorities like the FDA, or with other departments, the consequences can be huge.
"It's about protecting that relationship for future negotiations," says David Rogers, RAC-Devices, Senior Director of Regulatory affairs at Arthrex. “They have their own objectives that may not necessarily always align with yours. It is about trying to understand what they need, how they can benefit, and then you can start working through different scenarios where we can both achieve what we want.”
For Rogers, a session on negotiation was a standout section of his experience at the RAPS Kellogg Executive Development Program.
“I thought that was extremely informative and actually adjusted the way that I thought about my role with partners, with health authorities in the role of regulatory affairs,” he said. “It really reshaped the way I think of things. I didn't really think of myself as being weak in that area either. But it did give me a very sound foundation and a better frame of mind to approach those scenarios with, so that really stood out to me.”
Once you become a regulatory leader, you have opportunities to give back to the profession
While the regulatory field may no longer be in its infancy, it is still a profession full of people who fought for regulatory to get where it is now. It’s a field where experienced professionals feel a duty — or a passion — for preparing the next generation to navigate the field.
Regulatory professionals have chances to give guidance to younger professionals through the RAPS Mentoring Program, in RAPS’ Regulatory Exchange online community, at RAPS Chapter events, and more.
For regulatory leaders, the learning never really stops
Climbing the ladder in regulatory affairs means learning leadership skills like strategic decision-making, team management, cross-functional communication.
It also means tapping into the profession and staying informed on the changing landscape of regulation and of healthcare products. Reading or contributing to peer-reviewed publications like Regulatory Focus and presenting at or attending conferences are great ways to stay plugged in. Earning a regulatory credential like the Regulatory Affairs Certification (RAC), Regulatory Compliance Certifications (RCC) or Foundation In Regulatory Affairs (FRA) can validate your knowledge and help you stand out from the crowd.
Even if you are part of a large regulatory team, there is so much to learn and so much to keep track of in regulatory affairs.
You do not have to do it alone.
