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Regulatory Affairs Officers

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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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what are the key skills required for Regulatory Affairs Officers?



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