Quality Assurance Vs Regulatory Affairs Specialists Roles in Pharma

In the pharmaceutical industry, two vital roles are key to ensuring compliance, safety, and productivity: Quality Assurance (QA) Specialists and Regulatory Affairs (RA) Specialists. 

But whilst these roles are of similar importance and often collaborate closely behind the scenes of some of pharma’s latest and greatest innovations, their responsibilities, required skill sets, and potential career paths differ significantly.  

In this blog, we explore these differences in detail and highlight how QA Specialists and RA Specialists compare, to give you a better understanding of what each role entails and what skill, education and experience requirements are needed for individuals seeking to build a career in pharmaceutical quality assurance or regulatory affairs.  

What does a Pharmaceuticals QA Specialist do? 

Quality Assurance Specialists ensure that pharmaceutical products are manufactured consistently and meet stringent quality standards. Their work is process-oriented, focusing on Good Manufacturing Practices (GMP) and internal compliance, and often involves monitoring production activities, verifying that procedures are correctly followed, and identifying potential risks before they impact product quality.  

Suggested Read: The Importance of Process Engineering in Pharma 

QA Specialists also assist in the implementation of quality systems, reviewing of records and documentation, and the overseeing activities such as deviation investigations and corrective actions. As such, they have a key role in helping safeguard consumer safety and ensure that every product batch released to market adheres to all regulatory and company specifications. 

Key Responsibilities of a QA Specialist: 

• Process Validation: Ensuring each step in production consistently meets quality benchmarks. 

• Audit Management: Conducting internal and external audits to maintain compliance. 

• Batch Record Review: Verifying documentation for accuracy and integrity. 

• Deviation and CAPA Handling: Managing non-conformances and implementing corrective actions. 

• Quality Systems Oversight: Maintaining SOPs, QMS documentation, and change controls. 

Essential QA Specialist Skills: 

• Attention to detail 

• Analytical thinking 

• Strong communication 

• Knowledge of GMP and ISO standards 

Suggested Read: Career guide for working in Pharmaceuticals Quality Assurance 

What does a Pharmaceuticals RA Specialist do? 

Regulatory Affairs Specialists are integral to the relationship between pharmaceutical companies and regulatory bodies. Serving as their organisation's primary point of contact for regulatory agencies, they facilitate clear communication and guide teams through the complex approval process.  

Their role is documentation and regulation-focused, encompassing the preparation, submission, and maintenance of essential files and correspondence to support product registrations and modifications. This may involve interpreting evolving regulatory requirements, advising on compliance strategies, and ensuring that products meet both legal and scientific standards throughout their lifecycle.  

One of the key responsibilities of a RA Specialist is to stay informed of global regulatory changes and to foster collaboration across departments to ensure they remain compliant, in order to help safeguard public health and drive regulated, yet effective processes and production.  

Key Responsibilities of an RA Specialist: 

• Regulatory Submissions: Preparing documents for product approval. 

• Compliance Monitoring: Staying updated with global regulations and ensuring internal adherence. 

• Labelling and Packaging Review: Ensuring all product information complies with legal standards. 

• Lifecycle Management: Handling renewals, variations, and post-marketing surveillance. 

• Regulatory Strategy Development: Advising on clinical trials, product claims, and market access. 

Essential RA Specialist Skills: 

• Regulatory knowledge  

• Technical writing 

• Project management 

• Cross-functional collaboration 

Why are QA and RA Specialists more important than ever? 

With the rapid rise of gene therapies, biologics, and personalised medicines, the role of Quality Assurance and Regulatory Affairs Specialists is of ever-increasing importance across the pharmaceutical landscape.