Additional resources on this blog
Interview-based career profiles for this career area
Yavé Lozano, Medical Writer (Regulatory), ICON Vicente Tur, Director of Regulatory Affairs at Asphalion
A life science careers blog for early career researchers
This blog aims to inspire early career researchers exploring different career options. We provide interview-based profiles of life scientists working in diverse science-related careers and articles on a broad range of career-related topics, with new content added on a regular basis.
Many life science products are subject to national or international regulations to ensure that the products are safe and effective. The career area of regulatory affairs, quality control and safety centres around understanding, communicating and applying product/safety regulations, documenting relevant information, applying for required approvals, and coordinating related processes. These roles can be found in pharmaceutical companies, contract research/manufacturing organizations, and medical device companies; there are also roles in other sectors (e.g. food or national testing laboratories) that might be relevant for some scientific backgrounds. Every academic institution also has a safety office focused on biosafety and good working practices for safe research.
Regulatory affairs professionals oversee and manage the regulatory approval process for new products (e.g. medicines, and medical devices), and ensure that necessary processes are followed during product development. They can be employed directly by the company producing the product, or by consultancies who provide regulatory support on a contract basis. Additionally, a small number of positions also exist within the regulatory authorities themselves.
Depending on the role, tasks may include a subset of:
Quality positions include roles linked to quality control or assurance (QC or QA), and regulatory compliance for existing products. These roles involve ensuring that processes, systems and products comply with required standards (for example, ‘good manufacturing practices (GMP)), that each batch of product is checked for contaminants or other quality issues according to defined procedures, and developing related procedures and processes where needed. Specific tasks for QC roles may involve:
Assurance and compliance roles tend to focus at a broader level on the processes and documentation involved in the whole manufacturing process, including preparing for quality audits.
Safety
Generally, these roles require good attention to detail, a structured working style, strong communication skills and good interpersonal skills (e.g. to ensure that people from different departments submit their information on time, or follow processes they find cumbersome).
In our careers & skills survey, 6 regulatory & quality professionals told us the competencies they use most in their daily work The most frequently selected competencies were::
Language skills
The small number of responses to our careers and skills survey suggested that fluency in the local language is required for many, but not all, regulatory & quality roles. Those most likely to be possible without fluency in the local language are regulatory roles focused on FDA or European-level regulations in international companies. Roles involving national regulations, or where you will manage / communicate with quality control lab technicians, are likely to require the local language.
A PhD is generally not required to enter this career area, but a scientific background is helpful in most roles – for example, to understand the context of the information being handled in the submissions; and a PhD may be required for some more technical positions.
Some pharma companies offer traineeships and/or internships in regulatory affairs for those entering directly from a scientific (higher) degree or postdoc, and there are also training courses available that can help you to get familiar with the field before applying for positions within companies or agencies.
For ‘Quality’ positions, some training (e.g. in GMP) is available. However, while obtaining qualifications in the area may help you show your interest in a career change, additional qualifications are not strictly necessary – speakers in a quality control career webinar we held reported that recent PhD-hires to their company did not have GMP certification.
In our careers and skills survey, scientists working in regulatory affairs and quality told us that they appreciate that their work:
Interview-based career profiles for this career area
Yavé Lozano, Medical Writer (Regulatory), ICON Vicente Tur, Director of Regulatory Affairs at Asphalion
Regulatory Affairs
Quality assurance and control
Drug safety
Lab safety
For all:
For EMBL fellows
Within EMBL, further internal resources (e.g. recorded career seminars) can be found on our career exploration intranet pages.
For all career areas, we highly recommend first learning more about the careers using the resources above, then conducting informational interviews to gain further insights directly from former PhDs working in career areas that interest you.
Last update: Feb 2023