Pharmaceutical Regulatory Affairs Certificate Program

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.

• Prepare and/or review regulatory submissions to support clinical trial and marketing authorization activities.
• Provide high-quality CMC review of technical documentation i.e CTD Modules, Medical Data Packages, and Labelling documents.
• Regulatory filings in emerging markets. 
• Assist in the development of high-quality dossiers for various markets
• Review and Gap Analysis of Technical Documentation for Non-CTD/CTD dossier compilation.
• Work with the cross-functional team & review additional data generated in response to review comments per country. 
• Compile Dossiers. 
• Review the registration dossier (m1-m5) as per country-specific regulatory requirements etc.

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:

1. University degree in sciences and
2. Strong and practical understanding of the field either through work experience or obtained by pursuing a Certificate in Regulatory affairs.

The NAI RA certification aims to help you get your career started in regulatory affairs by building your knowledge, skills, and confidence in a practical and applied manner in the areas of importance in the RA field:

• Medical Devices and combination products
• Biologics and Biosimilars
• NDA and ANDA filings
• GMP, CMC, and CTD knowledge and experience
• Pharmacovigilance and post-market surveillance
• Labelling and advertising
• Prescription and over-the-counter drug products submission
• Patents and exclusivity

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.

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.