Regulatory Affairs Officer

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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.

    They combine their knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by a range of companies, meet the required legislation.

    They advise on and coordinate the approval and registration of:

    • pharmaceuticals;
    • veterinary medicines;
    • complementary medicines;
    • agrochemicals;
    • pesticides;
    • therapeutic devices;
    • cosmetics;
    • other products.

     

    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

     

    Duties

    • studying scientific and legal documents
    • gathering, evaluating, organizing, managing and collating information in a variety of formats
    • 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

    Relevant degree areas include life, physical, mathematical, applied and medical sciences. In particular, the following subjects may increase your chances:

    • biochemistry;
    • biology;
    • biomedical science;
    • biotechnology;
    • chemical and physical sciences;
    • chemistry;
    • life sciences;
    • medicine;
    • pharmacology;
    • pharmacy.

    A good honours degree is usually the minimum requirement for entry into the profession.

     

    Skills

    • IT skills
    • Negotiation skills
    • Analytical skills
    • Time management skills
    • Problem-solving skills
    • Presentation skills
    • Interpersonal skills
    • Communication skills

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