The Program is intended for individuals interested in joining the Regulatory department of pharmaceutical, biologic and medical device companies. Students of our regulatory affairs certification program will benefit from an applied and practical approach to Regulatory Affairs training which is complimented by hands-on projects. Apart from using the experience and knowledge gained directly in their professional careers, individuals who are, also, interested in the Regulatory Affairs Certification (RAC) Drug Exam can use this program as a preparation tool for their exam.
The program provides knowledge and insight into the current U.S. Professional Regulatory Affairs pathways for prescription and over-the-counter drugs, biologics, medical devices, as well as combination products. Topics such as promotion, packaging, labeling, patents, and exclusivity as well as an introduction to International Regulatory Affairs are part of the program curriculum, too. At the end of this program, students will have a good understanding of the regulatory framework around drug development, regulatory submissions, CTD, IND, NDA & ANDA, FDA regulatory submission requirements, Chemistry and Manufacturing Control and Post approval compliance and regulatory requirements, current Good Manufacturing Practices (cGMP) and quality concepts.
Regulatory Affairs is an attractive career choice for graduate students from a scientific background who enjoy communication and teamwork, are comfortable with multi-tasking, and are eager to expand their knowledge in the wide realms of the Pharmaceutical and medical device world. Regulatory Affairs is a rewarding, intellectually stimulating, and highly regarded profession within pharmaceutical and medical device companies.
The overall job outlook for Regulatory Affairs Specialist careers has been positive since 2004. Vacancies for this career have increased by 95.26 percent nationwide in that time, with an average growth of 5.95 percent per year. Demand for Regulatory Affairs Specialists is expected to go up, with an expected 25,840 new jobs filled by 2029. As new and developing industries become increasingly regulated, the demand for additional and specialized regulatory expertise will increase. It is estimated by the U.S. Bureau of Labor Statistics that the regulatory affairs field for pharma and medical devices will continue to grow at an average rate of eight percent.
Regulatory affairs professionals play an essential role in ensuring all pharmaceutical products comply with regulations governing the industry.
The Regulatory Affairs department is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities. Regulatory Affairs is actively involved in every stage of the development of new medicine and in the post-marketing activities with authorized medicinal products.
Regulatory affairs in many cases form the link between pharmaceutical companies and regulatory authorities, such as Food and Drugs Agency (FDA). At the company, they interact with the Research and Development (R&D), quality, compliance, and manufacturing staff to communicate their interpretation of federal and local guidelines.
Knowledge and insight into the current U.S. and global Professional Regulatory Affairs pathways for prescription and over-the-counter drugs, biologics, biosimilars, medical devices, as well as combination products. Knowledge of topics such as promotion, packaging, labeling, patents, CMC, CTD, NDA, ANDA, GMP, and post-approval submissions and compliance is a must for an aspiring regulatory affair professional. Additionally, you would need strong communication and leadership skills, as well as analytical thinking and problem-solving. Either during the development of regulatory strategies or presentations to stakeholders, these skills along with strong industry knowledge will be needed to excel.
This is a critical position within a company that requires monitoring trends and enforcing regulations for products and services to be sold.
Regulatory professionals’ average compensation continues to increase, according to RAPS’ recent compensation survey. The average total compensation for US-based regulatory professionals in recent years ranged from $292,625 for vice presidents to $108,627 for specialists. Respondents reported an average base salary increase of 5.6% from year to year.
There is no degree or career trajectory that promises success in the field. Successful regulatory affairs professionals typically have cross-functional training in areas such as science, pharmacy, engineering, marketing, and business. In some cases, the regulatory affairs professionals worked first in related industries, such as quality assurance and quality control, research and development, manufacturing, clinical research, lab sciences, pharmacology, and engineering. However, in general, regulatory affairs professionals have the following:
The certification builds your knowledge and indicates to the employer your level of motivation and interest in the industry as well as a documented proof of your knowledge. After the completion of the certification, you can confidently showcase your RA skills on your resume and elaborate on them in an interview.
Our student services department works with you one on one to help navigate the job application process including the building of your resume, preparing for an interview, and connecting you to industry.
You don’t have to complete the entire program. Each module will lead to its own certificate.
Our admission counselors can help you do a skill gap analysis to pick the appropriate course depending on your level of expertise.
No, you can extend the program end date for up to 48 weeks. Please contact our admin team for more information at info@neuageinstitute.com.
NAI online delivery is self-paced. Self-Paced Online (SPO) classes are entirely online courses that allow students to set their schedule as they move through the content at their own pace within an expected course completion deadline. Students log into their accounts to view their course syllabus and instructions on how to complete lessons, assignments, and exams. SPO courses are a flexible option for students with busy schedules, family responsibilities, and/or work obligations.
NAI courses are best for self-directed learners who can determine the amount of time needed to master the material provided in each module. Instructors provide valuable feedback on coursework and are available to provide additional instruction as needed when prompted by the student. While student-initiated communication is not mandatory, students are required to schedule a mid-term check-in with their instructor either by phone or video conference meeting.
A computer or mobile device with audio and internet access is required. The ability to view various document formats including PDF, Word and PowerPoint files is also required. We recommend using Google Chrome as the default browser for online learning with NAI.
NAI Online uses a combination of BrightSpace learning platform with Storyline 360, videos and PowerPoint to present class material. Most material is also provided as downloadable and printable PDFs.
Online courses use a combination of quizzes and exams, and project work which are submitted via our online training platform – BrightSpace. Questions may be in the format of multiple choice, true/false, fill in the blanks, short answers. Each course is unique and utilizes the best assessment tools for that material.
Self-funded Students
You may take term(s) off at any time. Please note, once you have started a term, you must complete the modules assigned to you during that term. If you need to take a break from your studies in the middle of the term due to unforeseen circumstances, you must consult with an NAI Online administrator for options.
Students on government or other financial assistance
You are required to strictly adhere to the start and end date specified on your financial aid application and as such you are not able to take any unscheduled break. You might be able to take more modules in a given term and have a lighter course load in the subsequent terms. Please contact us at 862-842-4200 or onlinelearning@neuageinstitute.com.
For full-time studies, learners can expect to spend about 20 hours per week towards their studies. For the full schedule of each program, refer to the online term table.
Please refer to the financial aid section of the website
Yes – we offer a flexible payment schedule for all online students. Contact us at onlinelearning@neuageinstitute.com to find out more about payment plans with NAI.
Yes, in general students move through levels. Each level must be completed prior to proceeding to the next level. Please review your program outline or contact us at onlinelearning@neuageinstitute.com for more information.
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