Regulatory Affairs Officer Duties & Responsibilities

The role and function of a Regulatory Affairs Officer includes the following duties and responsibilities:

Preparing submissions of licence variations and renewals to strict deadlines;
Ensuring that a company’s products comply with regulations;
Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to;
Negotiating with regulatory authorities for marketing authorisation;
Specifying storage, labelling and packaging requirements.
Collecting, collating and evaluating scientific data that has been researched by colleagues;
Developing and writing clear arguments and explanations for new product licences and licence renewals;
Planning and developing product trials and interpreting trial data;
Advising scientists and manufacturers on regulatory requirements;
Reviewing company practices and providing advice on changes to systems;
Liaising with, and making presentations to, regulatory authorities;
Monitoring and setting timelines for licence variations and renewal approvals;
Working with specialist computer software and resources;
Writing clear, accessible product labels and patient information leaflets;
Providing strategic advice to senior management throughout the development of a new product;
Project managing teams of colleagues involved with the development of new products;
Undertaking and managing regulatory inspections;

Note that this is not an exhaustive list of Regulatory Affairs Officer duties and responsibilities. Job functions for specific Regulatory Affairs Officer roles may vary, depending on the industry and type of employer.

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