What are regulatory affairs?
Developing a new medicine is a long and detailed process that can take anywhere from 10 to 12 years from the laboratory to being available in clinics. Throughout this journey, and even after a medicine is approved and, on the market, strict regulations are in place to ensure it is as safe and effective as possible.
Regulatory affairs are the field that handles all the rules and protocols surrounding a medicine’s development, ensuring they’re followed every step of the way.
To legally sell drugs in Kenya, you need a product registration certificate from the Pharmacy and Poisons Board (PPB) and an import permit for each consignment, processed through the Kenya National TradeNet System (KESWS)
People working in regulatory affairs are responsible for ensuring the medicine has gone through all the required testing, that the test results are properly analyzed, and that this information is submitted to the right regulatory body.
Careers in regulatory affairs
There is a wide variety of careers in the regulatory affairs field. Regulatory professionals carry titles such as:
- Regulatory Affairs Specialist
- Regulatory Affairs Manager
- Regulatory Affairs Director
- Compliance Specialist
- Food Safety inspector
- Clinical Research Associate
- Director of Quality Assurance
These regulatory professionals play a critical role in the development and distribution of medical technological advancements and disease-free food, improving people’s health and welfare around the world. But what do these professionals do daily?
The role of the regulatory professional
Regulatory professionals play a key role in ensuring that a company’s products meet all legal and scientific standards. Here’s what they typically do:
- They stay on top of ever-changing laws and regulations in every region where the company wants to sell its products.
- They offer advice on legal and scientific requirements to make sure everything is compliant.
- They gather, review, and assess scientific data to support product approvals.
- They prepare and submit registration documents to regulatory agencies, handling any follow-up negotiations needed to secure or maintain marketing approval for the products.
- At the highest level, they provide strategic and technical advice, contributing significantly to both the commercial and scientific success of a product’s development and the company as a whole.
- They help the company avoid potential issues, like poorly maintained records, flawed scientific reasoning, or unclear presentation of data.
On top of that, regulatory teams often get involved in shaping product marketing strategies. They’re also usually tasked with reviewing and approving packaging and advertising to make sure it aligns with regulations before it goes public.
Qualifications and training
If you’re aiming for a career in regulatory affairs, having a Life Sciences degree is a must. This field requires not only a solid understanding of the science behind medicine development but also the ability to explain that knowledge clearly to different audiences.
Getting started in regulatory affairs can be a bit tricky, though, because there aren’t many work experience opportunities available in this specific area.
Many graduates begin their careers in other roles within the pharmaceutical industry before moving into regulatory affairs.
While this might feel like a detour, it’s a great way to gain valuable insights into the drug development process, which is essential for success in regulatory roles.
The Pharmacy and Poisons Board (PPB) partners with universities to offer programs tailored to this field. If you’re currently studying life sciences at university, you might want to check out PPB Careers Fair—it’s a great place to learn more about regulatory affairs and explore potential opportunities.
Current trends in regulatory affairs
Kenya’s regulatory affairs landscape is evolving through key trends such as regulatory harmonization under the African Medicines Regulatory Harmonization Initiative (AMRHI), the integration of AI and automation in compliance processes, and a growing pharmaceutical regulatory market projected to expand at a CAGR of 6.81% from 2023 to 2030.
There is also an increased focus on local pharmaceutical manufacturing, with regulatory frameworks providing comprehensive compliance support. Additionally, regulatory frameworks continue to evolve, requiring professionals to stay updated on global standards and innovations to navigate market approvals effectively.
These trends highlight Kenya’s commitment to enhancing its regulatory environment, fostering innovation, and ensuring the availability of safe and effective pharmaceutical products.
Why it’s a great time to enter regulatory affairs.
Regulatory affairs are a fast-paced, ever-changing field that offers exciting opportunities for growth. With the demand for regulatory professionals continuing to rise, now is an ideal time to explore this career path.
By staying informed, sharpening your skills, gaining real-world experience, and building your network, you’ll be well on your way to making an impact in this dynamic industry.
Getting started in regulatory affairs
If you’re thinking about a career in regulatory affairs, there are a few important things to consider to figure out if it’s the right path for you. The most important step is to take a closer look at your personal and professional goals. Ask yourself how a career in regulatory affairs aligns with what you want to achieve—both in the short term and the long run.
Whether your goal is to make a meaningful impact, work on global challenges, or take on leadership roles in this dynamic field, a program like this can provide the foundation you need to get there.
Take the time to reflect on what you’re looking for in your career, and you’ll have a clearer picture of whether regulatory affairs are the right fit for you.