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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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