Regulatory approval is an essential stop in the journey from drug/product discovery to development and market launch. This informs the need for a rigorous regulatory affairs documentation process to ensure the correct information is accounted for.
The work of regulatory affairs document reviewers requires them to possess several critical skills to function optimally. While these skills come naturally to some, they can be acquired through the right regulatory affairs training.
Here, we discuss a few of the most important skills needed to carry out regulatory affairs document reviews successfully.
What Does a Regulatory Affairs Document Review Entail
A regulatory affairs document review entails the review of formal documents containing data related to the discovery, development, testing, production, and distribution of a pharmaceutical/biological/medical product or process. To do an excellent regulatory affairs document review, you must have certain information and possess the skills discussed in this article.
For this reason, our comprehensive training program covers regulatory affairs courses such as Good Manufacturing Practices, Global Regulatory Strategies, Food, and Edibles regulations, and more. These courses will provide you with knowledge about the job and equip you with the key skills requirements, five of which are listed below.
1. Attention to Detail in Regulatory Affairs Courses
While reviewing regulatory affairs documents, you’ll need to look for vital information about the design and conduct of all the product development processes. You’ll also need to confirm the accuracy and consistency of all the data and results obtained from the clinical trials.
The importance of these tasks calls for a meticulous approach to their execution, which is why you must be very vigilant on the job. Students are exposed to current trends in the food, cosmetics, and pharmaceutical industries through this ground-breaking curriculum.
2. Knowledge of Regulatory Requirements
Your regulatory approval applications stand a better chance of being approved if you know what the regulators are interested in seeing. This way, you know exactly what to include in the documents so that you can improve your odds.
To successfully review a regulatory affairs document, you should know all the relevant regulatory standards to comply with and the application guidelines to follow. The quality systems like GMP, HACCP, BRC, and SQF, as well as numerous regulatory tactics and the submission procedure, are all topics that QA/RA students learn about in our program.
3. Effective Communication Skills
In your job as a reviewer of regulatory affairs documents after regulatory affairs training, you’ll be standing in the gap between the regulators and the product development team. So you are responsible for relaying relevant information across the divide.
You should be able to extract key product information from the clinical trial teams and advise others on the product development training on what relevant data to collect and process. And to do this, you must have good interpersonal skills. This is so that you can get the word out as quickly as possible and get the results you’re looking for.
4. Good Analytical and Critical-Thinking Skills
A successful approval application often results from a rigorous data collection, analysis, review, and validation process. So you can expect to be stacked with a flurry of test results and process/methodology data, vital product documentation, and quality control information throughout the process.
You should also be able to make sense of all the data to figure out problem areas, solutions, and alternatives promptly. To thrive under such intense conditions, you must maintain a clear head and think quickly.
5. Organizational and Time-management skills
Pharmaceutical companies must often complete their New drug application (NDA) or Premarket approval application processes over specific time frames. This is probably in response to the demands of regulatory deadlines or the fulfillment of all their obligations to relevant stakeholders.
Therefore, you must be able to manage time properly to file reports and affect any relevant process/product changes on time. This requires careful planning and precise execution of tasks to be achieved. And it also means that you must be able to organize workflow promptly and effectively.
Do you wish to learn more about regulatory affairs documents through our regulatory affairs program?
Contact AAPS to learn more.