Roles and responsibilities

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:

• keep up to date with national and/or international regulations.
• providing strategic advice to research and development teams on processes and requirements, with the aim of ensuring that the product will be developed in a way that is compatible with the regulatory process – for example, that records and documentation are completed. 
• coordinating collation, formatting and submission of relevant documentation for approval of new products, clinical trials, licence renewals and changes in the wording of packing/product inserts; for example, interacting with the scientists and medical writers compiling different sections of the reports. Regulatory affairs professionals may also be involved in writing some parts of the dossier.
• making presentations to regulatory authorities like the US Food and Drug Administration (FDA)/European Medicines Agency (EMA), communicating with the agencies regarding current submissions or within regulatory authorities.
• coordinating assessment of submissions.
• managing any regulatory inspections. 

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:

• overseeing (senior roles) or carrying out (junior roles) lab-based sample testing to ensure e.g. homogeneity and purity with relevant techniques (e.g. HPLC, LC/GC-MS, ELISA, Octet^®) and absence of microbial contamination.
• project management around the quality control process/related work.
• completing reports and other documentation e.g. standard operating procedures (SOPs) and reports on trends; presenting data.
• approving the release of product batches (more senior roles).
• identify potential improvements in systems.
• investigating root causes and proposing ‘corrective and preventative actions’ when a potential quality issue is identified (e.g. ‘deviations’ from procedure due to human error or equipment failure, or deviations from expected values in the laboratory tests).

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

• drug safety/pharmacovigilance investigates possible safety issues with products in development or already on the market. They receive and evaluate reports of adverse events, and write periodic safety reports. Entry-level roles may also involve coding reports and entering them into a central database.
• lab safety: role in institutes (and presumably industry) – for example biosafety – advising researchers/management on legal requirements and risks around lab and research safety (e.g. containment levels for different infectious disease research), promoting good practice and responding to/documenting lab accidents etc.

Career entry and progression

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.

Knowledge and skills

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 and skills survey, 6 regulatory and quality professionals told us the competencies they use most in their daily work  The most frequently selected competencies were::

• teamwork (selected by 100% of respondents)
• organization (selected by 100%)
• writing (selected by 67%)
• effective communication (selected by 67%)
• resilient problem solving  (selected by 67%)

Language requirements

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 and 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.