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Regulatory affairs officers act as a link between companies and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation.
Regulatory affairs officers ensure that products such as cosmetics, pharmaceuticals, and veterinary medicines meet legislative requirements.
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 regulations set by 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
analysing complicated information, including trial 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.
Qualifications and training required
You can only become a regulatory affairs officer if you have a relevant degree such as chemistry, physics, biochemistry, biotechnology, pharmacy, medicinal chemistry, biomedical science, life or applied science.
Postdoctoral 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.
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
MHRA
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