1: What Are Quality Assurance and Regulatory Affairs Roles?

What does someone in Quality Assurance actually do day-to-day?
Quality Assurance is process-oriented and focuses on eliminating all process variation by creating, revising and strictly implementing a set of tightly and precisely defined processes, procedures and checklists that when exactly followed, ensure the final quality of the product.

Quality Assurance professionals are responsible for ensuring that pharmaceutical products are manufactured consistently, safely, and in compliance with Good Manufacturing Practice (GMP). Their day-to-day tasks include reviewing and approving batch records, handling deviations, approving changes to procedures, supporting audits, and overseeing training and documentation systems.

What does someone in Regulatory Affairs actually do day-to-day?
Regulatory Affairs professionals are responsible for preparing, submitting, and maintaining documentation required by regulatory authorities to get and keep approval to sell a pharmaceutical product. Their work includes compiling marketing authorisation applications, submitting product variations, responding to questions from regulators, and tracking global regulatory requirements. They also ensure that product labelling, packaging, and documentation comply with all applicable laws.

Who do they interact with?
Quality Assurance professionals interact with manufacturing staff, quality control analysts, validation teams, engineering, and supply chain. Regulatory Affairs professionals interact with Quality Assurance, R&D, packaging, clinical, medical affairs, and regulatory agencies. Both roles are cross-functional but focus on different parts of the product lifecycle.

2: Where Do These Roles Sit in a Company?

Which departments or functions are Quality Assurance and Regulatory Affairs part of?
Quality Assurance is part of the quality function and sits within the manufacturing organisation. Regulatory Affairs is part of the regulatory or medical function and typically sit with corporate, global operations.

Who do they report to?
Quality Assurance professionals usually report to a Quality Manager or Site Quality Lead. Regulatory Affairs professionals typically report to a Regulatory Affairs Manager or Director, depending on the company size and structure.

Do they work more in manufacturing, R&D, or corporate settings?
Quality Assurance roles are typically located at manufacturing sites and closely tied to manufacturing. Regulatory Affairs roles are more often based in corporate offices or regional hubs and work closely with R&D and global strategy teams.

3: Qualifications & Experience

What degrees are typical for Quality Assurance vs. Regulatory Affairs?
For Quality Assurance, degrees in chemistry, biochemistry, biotechnology, pharmaceutical science, are common. For Regulatory Affairs, degrees in pharmceutical science, biochemistry, or biomedical sciences are typical. There is a lot of overlap.

What kind of work experience helps?
Quality Assurance roles often value hands-on experience in manufacturing, or document control. Regulatory Affairs roles benefit from experience with regulatory submissions, documentation systems. Previous Quality Assurance or manufacturing experience is often seen as valuable when transitioning into Regulatory Affairs.

What skills are non-negotiable for each?
Quality Assurance requires attention to detail, a working knowledge of GMP, the ability to interpret procedures, and comfort working in structured environments. Regulatory Affairs requires strong written communication skills, document management ability, knowledge of regulatory guidelines, and comfort interpreting technical and legal information.

Summary: Key Differences Between Quality Assurance and Regulatory Affairs

4: Entry Pathways – Ireland vs. USA

How do people get into Quality Assurance roles in Ireland?
Most people enter Quality Assurance roles from a variety of paths such as direct from university, gaining experience in manufacturing, or through graduate programs focused on pharmaceutical operations. Document control or production support roles are also common starting points.

How do they move from Quality Assurance into Regulatory Affairs?
In Ireland, many Regulatory Affairs professionals begin in Quality Assurance. After gaining experience with GMP systems, documentation, and production processes, some move into Regulatory Affairs by taking on responsibilities related to product change control, or submissions support. Or they may go back to university and study regulatory science.

What does the US pathway look like?
In the USA, it seems to be more common for graduates to move directly into Regulatory Affairs, particularly if they studied pharmacy, biomedical sciences, or regulatory science. Entry-level Regulatory Affairs associate roles are more common, and some universities offer formal Regulatory Affairs training or postgraduate programs as part of the academic route.

5: Career Progression

What does a career ladder look like for Quality Assurance vs Regulatory Affairs?
Quality Assurance careers typically progress from Quality Assurance Associate to Quality Assurance Specialist or Quality Assurance Supervisor, and then to Quality Assurance Manager, Quality Assurance Director, or Global Quality roles. Regulatory Affairs careers typically progress from Regulatory Affairs Associate to Regulatory Affairs Specialist, Manager, and then into global or strategic Regulatory Affairs roles.

Can you move from Quality Assurance to Regulatory Affairs later in your career?
Yes. This seems to be especially common in Ireland. People with Quality Assurance experience — especially in document control, validation  often move into Regulatory Affairs roles.

6: Which Role Is Right for You?

What kinds of people thrive in Quality Assurance?
People who like structure, process, and operational oversight do well in Quality Assurance. It suits those who are comfortable working in regulated environments and enjoy routine, compliance, and attention to detail.

What kinds of people thrive in Regulatory Affairs?
Regulatory Affairs suits people who enjoy research, writing, interpreting technical regulations, and project-based work. It also appeals to people who like cross-functional collaboration and working with external authorities.

What are the pros and cons of each career path?

Quality Assurance pros:
– Clear entry path
– Strong foundation in GMP
– Broad exposure to manufacturing and operations
– High demand across sites

Quality Assurance cons:
– May involve shift work
– Repetitive tasks depending on role
– Limited flexibility at some sites
– Very documentation focused

Regulatory Affairs pros:
– Strategic and cross-functional
– Often office-based or hybrid
– Involved in global product lifecycle

Regulatory Affairs cons:
– Harder to enter directly in some regions
– Requires strong writing and regulatory knowledge
– Can involve tight timelines and complex regulations