This article outlines how to start a career in regulatory affairs without prior experience. It highlights key skills, entry-level roles, and actionable steps to break into the field, with Regulatory Academy as the ideal launchpad.
Breaking Into Regulatory Affairs
Breaking into regulatory affairs can feel intimidating — especially if you don’t have prior experience in the field. Whether you’re coming from a life sciences background, healthcare, or another technical field, the path to becoming a regulatory professional is more accessible than you think. In this guide, we’ll break down the role of regulatory affairs, the qualifications you actually need, and the exact steps to take to get started in one of the most in-demand and well-paying careers in the life sciences industry.
What Is Regulatory Affairs?
Regulatory affairs professionals ensure that products like medical devices, pharmaceuticals, biologics, and diagnostics meet the safety and compliance standards set by government agencies like the FDA, EMA, and others. They work closely with R&D, clinical, and quality teams to prepare submissions, interpret regulations, and support the product lifecycle from concept to market.
Skills That Matter More Than Experience
You don’t need prior industry experience to be considered for entry-level roles — what you do need is:
A foundational understanding of regulatory processes
Strong communication and documentation skills
Scientific or technical literacy (especially in biology, chemistry, or engineering)
Attention to detail and a process-oriented mindset
A willingness to learn and follow global compliance standards
Step-by-Step: How to Get Into Regulatory
1. Start with Online Training or Courses
Gain a foundational understanding of medical device or pharmaceutical regulations (like FDA 21 CFR, ISO 13485, EU MDR). You don’t need a 2-year degree — targeted learning through platforms like Regulatory Academy can get you started quickly.
2. Join a Community
Surround yourself with other regulatory professionals, ask questions, and learn from those ahead of you. Regulatory Academy offers a dedicated SKOOL community for just this reason.
3. Build a Regulatory Resume
Tailor your resume to highlight transferable skills (project coordination, documentation, SOP writing, etc.). Use proper terminology — mention GxP, submissions, technical files, and regulatory strategy where applicable.
4. Apply for Entry-Level Roles
Look for positions such as:
Regulatory Affairs Assistant
Regulatory Affairs Associate
Document Control Specialist
Quality & Regulatory Coordinator
Use RegulatoryJobs.com to find targeted roles in Med Tech, Pharma, and Biotech.
5. Be Prepared for the Interview
Understand how regulatory professionals add value — be ready to discuss how you follow rules, manage complexity, and communicate across teams. Show curiosity about compliance, standards, and safety.
Why Now Is the Best Time to Enter Regulatory Affairs
The demand for regulatory professionals is growing — especially in medical technology and biotech. With increasing global scrutiny and new regulatory frameworks (like EU MDR and FDA modernization), companies are hiring at all levels to keep up. If you take focused action now, you can position yourself for long-term success in a high-paying, stable field.
Join Regulatory Academy
Regulatory Academy is designed to give you the foundation, community, and support you need to launch a successful regulatory career — even if you're just getting started. With practical courses, career guidance, and insider knowledge from seasoned professionals, this is where the next generation of regulatory leaders begins.
