Regulatory | Taj Life Sciences

Regulatory:

Regulatory affairs liaisons manage the process of working with project teams and interacting with the regulatory health agencies, such as the Food and Drug Administration (FDA) or the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). In addition to regulatory affairs liaisons positions, there are a vast array of other career opportunities, such as managing and submitting regulatory information, document management, and publishing.

Positions within regulatory affairs offer excellent job security. The reason is simply supply and demand: not enough people today have experience in regulatory affairs and at the same time, the FDA has increased its standards, requiring more supporting studies and paperwork before products can be approved for human use. To be successful in this position, it helps to be very detail- and process-oriented, and to possess excellent writing, communication, and interpersonal skills.

Role of the company regulatory affairs department:

Each pharmaceutical organization must have a regulatory affairs department. This department should have a full understanding of the requirements applying to the company?s products and should also act as the repository for the information provided to the regulatory authorities in support of applications and changes to the company?s marketing authorization. This should include the countries where the products are marketed, ?local? regulatory requirements, and the up-to-date registration status.

The regulatory affairs department should also have information about the company?s authorization(s), to manufacture, where appropriate to import and to distribute the company?s products. Students are advised to ensure that they know how to obtain this information and how to stay up-to-date with regulatory requirements.

Pharmacovigilance:

• Pharmacovigilance is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The legal framework for pharmacovigilance for medicinal products in the EU/European Economic Area (EEA) is set out in a number of Directives, which describe the obligations of marketing authorization holders and the regulatory authorities. This requires them to set up a system for pharmacovigilance in order to:

• Collect, collate, and evaluate information about reported and suspected adverse reactions;

• Share relevant information to allow all parties involved to meet their obligations and discharge their responsibilities.