Regulatory affairs officer

Regulatory affairs officer job description: Typical employers | Qualifications and training | Key skills | Useful links | Find jobs and courses

Key duties of the job include:

• studying scientific and legal documents
• gathering, evaluating, organising, managing and collating information in a variety of formats
• ensuring compliance with MHRA regulations
• 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
• analysing complicated information, including trials data
• offering advice about company policies, practices and systems
• obtaining marketing permission
• outlining requirements for labelling, storage and packaging
• using a variety of specialist computer applications
• liaising and negotiating with regulatory authorities
• providing advice about regulations to manufacturers/scientists
• writing comprehensible, user-friendly, clear product information leaflets and labels
• ensuring that quality standards are met and submissions meet strict deadlines
• preparing documentation.

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
• the Medicines and Healthcare Products Regulatory Agency (MHRA).

Vacancies are advertised online, by careers services, in national newspapers and in scientific publications such as New Scientist, Science, Microbiology and The Pharmaceutical Journal. Specialist recruitment agencies also occasionally advertise opportunities. Speculative applications to major pharmaceutical and chemical companies are advisable.

Qualifications and training required

The minimum necessary qualification is a 2.1 in an appropriate subject (chemistry, physics, biochemistry, biotechnology, pharmacy, medicinal chemistry, biomedical science, life or applied science).

A relevant postgraduate qualification (PhD or research-based MSc) is also helpful, particularly for permanent positions. Post-doctoral research, practical research or laboratory work experience is also beneficial - regulatory affairs experience is particularly sought after.

Key skills for regulatory affairs officers

• IT skills
• negotiation skills
• analytical skills
• time management skills
• problem solving skills
• presentation skills
• interpersonal skills
• communication skills.

An understanding and appreciation of relevant legal, scientific and manufacturing areas is also necessary.