Regulatory affairs is a discipline that consists of assessing products before they’re released to the market to make sure they meet regulatory compliance. This discipline covers a broad spectrum of products and industries including food, pharmaceutical, medical devices, agrochemicals, etc.
Regulatory affairs specialists are the bridge between three entities: government authorities, customers, and manufacturers. They make sure products are safe for consumption, help companies avoid legal problems, and follow regulatory rules.
There are several organizations that regulate the manufacturing, advertising, and release of food and drug products. Some of the most relevant institutions are the Food and Drug Administration (FDA) and The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
There is some flexibility in manufacturing rules, so regulatory affairs specialists help companies interpret these regulations. Authorities hold companies accountable for the way they interpret these rules, so the RA team plays a huge role in advising companies with the best interpretation.
There is a shortage of regulatory affairs talent and a huge demand for these professionals. Regulatory authorities are constantly updating rules and legal compliance, so companies need to stay up-to-date with those changes.
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A regulatory affairs specialist is responsible for helping companies release safe products that meet legal compliance. They conduct tests and evaluate the manufacturing process to ensure everything is done under the legal scope.
Regulatory affairs specialists must also make sure that product labels match accurately nutritional and safety information. The product must do exactly what it advertises on its label. They will also perform post-marketing follow-ups.
Regulatory affairs specialists must keep track of any changes and trends in regulatory compliance. They’ll frequently meet with authorities and stakeholders and often be part of the negotiation processes. If the manufacturer is facing legal issues, the regulatory affairs specialist will participate in conflict resolution.
As a regulatory specialist, you must be familiar with different laws and regulatory authorities because this is a broad field. You might work in pharmaceuticals, agrochemicals, and even food manufacturing. Each of those fields has different regulatory compliance that you must understand. Try to demonstrate your proficiency in regulatory laws in your resume.
Regulatory affairs certifications are not usually mandatory, but they can surely help you increase your odds of getting a job. They validate your skills and make you seem authoritative. The Regulatory Affairs Certification (RAC) is the most relevant one in the industry.
A regulatory affairs manager is the head of the RA team. They will oversee the work of other regulatory affairs specialists and assign duties. RA managers meet and maintain long-term professional relationships with regulatory bodies. They also assist multiple teams in the manufacturing process to ensure they follow regulatory compliance.
As a regulatory affairs manager, you will also conduct research and create reports to share with stakeholders. They will also respond to information requests from regulatory agencies. A RA manager must also evaluate how regulatory compliance will affect the company's operations and finances.
As a RA manager, you will supervise multiple teams to ensure all operations meet regulatory laws. This requires leadership and interpersonal skills to resolve conflicts and guide colleagues. You can mention your experience with different teams in your resume to emphasize your ability to work with multiple groups.
Adding quantifiable accomplishments to your resume is a great way to describe your value. You can talk about risk management, mention how you improved a company’s operations in terms of regulatory laws, etc.
A regulatory affairs associate is the company’s representative in legal negotiations with regulatory agencies. They assist companies in the process of getting their products approved by regulatory bodies such as the FDA and the ICH. RA associates collect documents and evaluate manufacturing processes.
Considering this is an entry-level position, you may not have extensive work experience. However, this doesn’t mean you can’t demonstrate your value. You can include extracurricular activities in which you practiced regulatory affairs research.
You have some competencies you developed in other roles that are fundamental to regulatory affairs. You can rely on transferable skills to showcase your value. Abilities such as research, data analytics, and reporting, are crucial in a regulatory affairs associate role. However, these are just a few ideas, it will all depend on your particular experience.
We reached out to hiring managers at top companies in the regulatory affairs industry, such as Pfizer, Johnson & Johnson, and Novartis, to gather their insights on what makes a standout regulatory affairs resume. Based on their feedback and our own expertise, we've compiled a list of essential tips to help you craft a compelling resume that will catch the attention of hiring managers in this competitive field.
Employers want to see that you have a deep understanding of the regulatory landscape in your industry. In your resume, showcase your knowledge of:
For example:
Managed the preparation and submission of 10+ INDs and 3 NDAs, ensuring compliance with FDA regulations and guidance documents.
A resume summary for a regulatory affairs position is optional, but it can be a strategic way to provide additional context about your background and highlight key qualifications. While your resume itself should already be a concise summary of your skills and experience, a summary can be particularly useful if you're a career changer and your past experience doesn't directly align with regulatory affairs, or if you're an experienced professional with an extensive background.
However, it's crucial to avoid using an objective statement, as these are outdated and focus on your own goals rather than how you can contribute to the employer. Instead, craft a compelling summary that showcases your most relevant strengths and expertise without repeating information already covered in other sections of your resume.
Your work experience section is the heart of your resume as a regulatory affairs professional. It's where you showcase your relevant experience, key accomplishments, and the value you've delivered for previous employers. Highlighting the right achievements and details is critical to demonstrate you have the regulatory affairs expertise employers are looking for.
The education section of your regulatory affairs resume should be concise and highlight your relevant qualifications. This section is especially important if you are a recent graduate or have limited work experience. Here are some tips to help you craft a strong education section:
As a regulatory specialist, you will be the bridge between authorities and company stakeholders. Therefore, your communication skills must be on point. You will be translating highly complex concepts and laws to business owners and colleagues. The best way to demonstrate your communication skills is by writing an easy-to-understand resume.
There are several action verbs that will help you describe your role as a regulatory affairs specialist. Instead of using vague phrases like “responsible for” or “in charge of”, you can use bulleted lists with action verbs like “interpreted”, “examined”, or “executed”. This way you are more precise and give a clear view of your potential.
For a full list of effective resume action verbs, visit Resume Action Verbs.
Regulatory affairs is a highly technical profession that combines chemistry and legal compliance. You should be able to demonstrate your competencies and the best way to do it is by showcasing your skills. The skills section is where you can showcase your value as a regulatory affairs specialist.
Try to demonstrate your knowledge of regulatory laws, evaluation techniques, and data analytics skills. If you need more inspiration with technical skills for your regulatory affairs resume, check below. We have compiled some of the most relevant competencies for this profession.
You can include the above skills in a dedicated Skills section on your resume, or weave them in your experience. Here's how you might create your dedicated skills section:
This word cloud highlights the important keywords that appear on Regulatory Affairs job descriptions and resumes. The bigger the word, the more frequently it appears on job postings, and the more 'important' it is.
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