Regulatory affairs officer: job description

Regulatory affairs officer : Salaries | Employers | Qualifications and training | Key skills

Regulatory affairs officers ensure that products such as foods, cosmetics, pharmaceuticals and veterinary medicines – and the steps involved in developing, testing and marketing them – meet legislative requirements.

Typical duties include:

• studying scientific and legal documents to check they meet legal requirements.
• gathering, evaluating, organising, managing and collating information in a variety of formats.
• submitting information and responding to queries from bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA).
• maintaining familiarity with company product ranges.
• planning, undertaking and overseeing product trials and regulatory inspections.
• keeping up to date with changes in regulatory legislation and guidelines.
• offering advice about regulations, company policies, practices and systems.
• obtaining marketing permission.
• outlining requirements for labelling, storage and packaging, and approving information leaflets and labels.
• liaising and negotiating with regulatory authorities.

Graduate salaries

Salary survey websites suggest that earnings for regulatory affairs officers tend to start at around £20,000. However, this increases with experience: average salaries in this field are around £40,000.

Typical employers of regulatory affairs officers

• Chemicals manufacturers.
• Pharmaceuticals manufacturers.
• Herbal treatments manufacturers.
• Pesticides manufacturers.
• Medical devices manufacturers.
• Veterinary treatment manufacturers.
• Homeopathic medicine manufacturers.
• Research organisations.

As an alternative to working in-house, you could also work for an agency specialising in providing regulatory affairs advice to companies in particular sectors. With experience, you could also work as a freelance regulatory affairs consultant.

Vacancies for graduate jobs are advertised on targetjobs , and by careers services and university departments. Scientific publications’ jobs sites also include details of vacancies. You will also find vacancies advertised by specialist recruitment agencies.

Qualifications and training required

You can only become a regulatory affairs officer if you have a relevant degree in a subject such as chemistry, physics, biochemistry, biotechnology, pharmacy, medicinal chemistry, biomedical science, life or applied science. A relevant postgraduate qualification (PhD or research-based MSc) may be advantageous. Read our article on scientific postgraduate study to explore your different options.

Postdoctoral research, practical research or laboratory work experience is also beneficial. Regulatory affairs experience is particularly sought after.

Some employers offer level 7 apprenticeships in regulatory affairs, for which you usually need at least a 2.2 degree or above in a science or law degree to be eligible. On completion, you can apply for membership with The Organisation for Professionals in Regulatory Affairs (TOPRA), or apply for professional registration as a registered scientist through TOPRA or the Science Council.

Key skills for regulatory affairs officers

• The ability to take in and work with complex and technical information.
• Excellent IT skills.
• Negotiation skills.
• Analytical skills .
• Time management skills .
• Problem-solving skills .
• Presentation skills.
• Interpersonal skills.
• Communication skills, both written and oral .