In the pharmaceutical industry, people often discuss Regulatory Affairs (RA) and Quality Assurance (QA) together, but they represent two very different functions. Both RA and QA are important functions that act as pillars to ensure patients receive high-quality, safe and efficacious medicines. Yet, while they interact closely with each other, the degree of responsibility, focus, and skills are often very different. Understanding the distinctions between RA and QA is very important for people already in the pharmaceutical industry, but also for students and professionals considering a career in pharma. This article will look at the differences between Regulatory Affairs vs. Quality Assurance, what each contribution, how they interact, and which career path may be best for you.
The Role of Regulatory Affairs in Pharma
Regulatory Affairs or RA, is what connects a pharmaceutical company with national or international regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and the Central Drugs Standard Control Organization (CDSCO) in India. Regulatory Affairs professionals oversee that a drug, biologic, or medical device meets the nations legal and regulatory standards for the market in which it is to be sold. This is accomplished by overseeing the product as it moves through its entire lifecycle from the earliest parts of drug development to post-marketing surveillance. Regulatory Affairs are responsible for developing or compiling needed documentation for the submission of any product, whether it be a new drug application, biologic, clinical trial application, marketing authorization submission, or periodic safety updates. Regulatory Affairs stay current with regulations that continually change across countries and advise research, manufacturers, and marketing teams of compliance requirements. Regulatory Affairs work is dual purpose, being strategic as well as technical; competent Regulatory Affairs specialists know the regulations but are also key in helping their companies develop the best pathway to get their product on the market quickly and efficiently.
Some of the important roles of Regulatory Affairs in the pharmaceutical industry include:
- Preparing and submitting dossiers to obtain product registration.
- Managing inspection and regulatory audits.
- Reviewing product labels, packaging, and promotional material for compliance with regulations.
- Managing variations, renewals and post-approval changes.
- Coordinating responses to inquiries from regulatory agencies.
RA ultimately strives for compliance ensuring a product is compliant with all regulatory requirements to be marketed and consumed in a particular market.
The Role of Quality Assurance in Pharma
Quality Assurance, or QA, is the process of ensuring that each product is produced to established quality standards and that processes are able to avoid defects rather than only finding defects. Quality Source deals mainly with regulators external to the organization whereas Quality Assurance takes place internally in manufacturing and
operating systems. QA has to be put into place before the product is ever made. QA groups develop and manage quality systems in compliance with Good Manufacturing Processes (GMP), Good Clinical Processes (GCP) and other quality requirements. In QA, Standard Operating Procedures (SOPs) are designed; staff are trained; equipment is validated; controls are established to ensure every phase of the process continuously produces the desired results.
Some of the typical responsibilities of a QA professional in the pharmaceutical industry are:
- Establish and maintain quality management systems.
- Conduct internal audits to confirm adherence to SOPs and GMP standards.
- Approve or reject raw materials, in-process materials and finished products
- Investigate and resolve deviations and non-conformity.
- Review and approve batch manufacturing records.
A guiding philosophy of QA is “right first time” build quality into the process to eliminate defects in the first place.
How RA and QA Work Together
While RA and QA address different issues, they are uniquely interrelated. RA depends on Quality Assurance systems for the documentation and evidence needed to submit to regulatory agencies. For example, RA needs the QA, records of the essence of manufacturing including quality checks and deviation reports in order to develop a drug registration dossier. QA teams, on the other hand, must design their quality system to meet the expectations of regulations, which means QA has to understand those expectations communicated by the RA. Working together ensures legal and quality requirements are met without interference and delays.
Skills Required for RA and QA Careers
While both RA and QA require attention to detail, the actual skill sets emphasize different components.
Regulatory Affairs:
• Robust knowledge of international regulatory guidelines (ICH, FDA, EMA, CDSCO).
• Technical writing skills for writing submissions.
• Ability to think strategically to determine a regulatory path.
• Ability to communicate regularly with agencies and internal colleagues.
Quality Assurance:
• Robust knowledge of a variety of applicable standards (GMP, GCP, GLP, ISO).
• Analytical skills to assess deviations and trends.
• Process-focused advocacy to design preventive controls.
• Auditing skills to participate in internal and external audit.
Which is the Better Career Choice?
Which is better as a career in the pharmaceutical industry Regulatory Affairs (RA) or Quality Assurance (QA)?
The answer to this question depends on your interests and strengths, but if you have an interest in strategic problem solving, global regulations and documentation, then RA is a viable option as it requires working directly with regulatory bodies, determining how to submit approvals, and keeping up-to-date with changing regulations. If you enjoy process improvement, making sure things aren’t wrong, and protecting operational performance, then QA might be a better option than RA because a strong focus is placed on ensuring work is done with the best standard. Understanding manufacturing and laboratory processes is also really important in QA, unlike RA, where you may not be involved in any work in the plant. Both RA and QA are in demand across the pharmaceutical industry and are careers that provide stability to revenue for long periods of time. While RA usually has a global component, which may drive an interest compared to QA, QA may be more reasonable, while RA is more operational.
Why the Pharma Industry Needs Both
The success of a pharmaceutical product relies on both functions working in tandem. No Regulatory Affairs as a practical matter, the product might never make it through to the point of sale. No Quality Assurance, the product may never be made available for sale that meets necessary safety and quality standards. Together, they create the essence of compliance and quality in the field. The end result is that patients are provided with high quality medicines they can trust.
Conclusion
The debate between Regulatory Affairs and Quality Assurance isn’t about which is more important, both are vital in pharma. RA ensures compliance with external regulations, while QA safeguards internal quality. If you’re aiming to build a career in either field, CareerInPharma offers expert-led, industry-focused online programs that equip you with practical skills in RA processes, GMP, auditing, SOPs, and more, along with interview prep and resume support to boost your employability. Enroll now and take your first step toward a rewarding RA or QA career.
FAQs about Regulatory Affairs vs. Quality Assurance
1. What is the difference between Regulatory Affairs (RA) and Quality Assurance (QA) in pharma?
RA verifies that a company follows all external regulations and guidelines to bring a drug to market, while QA ensures that internal processes continuously provide safe and high-quality products.
2. Which role has more of a focus on documentation for approvals RA or QA?
Significant part of Regulatory Affairs involves preparing and submitting regulatory documents for approvals such as dossiers, variation files, and product registrations to health authorities.
3. Who is responsible for ensuring that the GMP (Good Manufacturing Practices) are followed?
Quality Assurance has the biggest responsibility for ensuring that the GMP is followed, including conducting audits, writing SOPs, handling deviations, and validation.
4. Can a person move from QA to RA or vice versa?
Yes, with some further training and exposure. While the main objectives are different, the two roles require an understanding of pharma regulations, documentation, and compliance which allows for marking change of career.
5. Which has better growth potential as a career RA or QA?
Quality Assurance and Regulatory Affairs both have strong growth opportunities. Regulatory Affairs can explore future gazing with their planning function along with their global strategy to assess market expansion, while Quality Assurance can lead manufacturer quality auditing and expand regulatory compliance and responsibilities. The better choice depends upon the individual’s areas for improvement.
