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Regulatory Affairs Internship and Various Aspects of the Job

by: kristinakoopman61 on Date: Tue, 30 Apr 2013 Time: 7:42 AM

The regulatory affairs specialist is responsible for preparing and filing demands of products of some company for regulatory approval. Unlike pharmaceutical companies, the lesser means of biotechnology companies forces them to towards consultants or prioritize experienced candidates. The regulatory affairs internship in biotechnology industry includes a lot of responsibility and plays a crucial role in every stage of the process. However, when it comes to pharmaceutical industry, the tasks mostly include administrative jobs.

In order to get qualified for regulatory affairs internship, the person should have University degree in sciences like biology, toxicology, chemistry, pharmacology, etc. There are lots of private as well as government agencies offering internship opportunities to people studying in college. There are different professional organisations like TOPRA or RACS from where one can get certification in regulatory affairs. The summer internship programs offered by most private organisations usually continue for a period of ten weeks.

The key responsibilities during regulatory affairs internship include:

. Studying legal and scientific documents
. Gathering, organising, evaluating, collating and managing information in different types of formats
. Maintaining compliance with the MHRA regulations
. Maintaining familiarity with the different products of the company
. Planning, overseeing and undertaking regulatory inspections and product trials
. To be well aware of any changes in regulatory guidelines and legislation
. Analysing information of complex nature including trails data
. Come up with advices related to company practises, policy and systems
. Gaining marketing permission
. Outlining the requirements for packaging, labelling and storage
. Using different types of advanced computer applications
. Negotiating and liaising with regulatory authorities
. Offering advice related to regulations to scientists and manufacturers
. Writing user-friendly, clear and comprehensible product information labels and leaflets
. Preparing documentation
. Making sure that submissions meet the guidelines and quality standards are maintained

Some of the key skills which are required for the position of regulatory affairs specialist are:

. Negotiation skills
. IT skills
. Time Management skills
. Analytical skills
. Presentation skills
. Problem solving skills
. Interpersonal skills
. Communication skills

There are different industries involved with regulatory affairs like banking, energy, medical devices and pharmaceutical. This is a job where one gradually advances in different stages. After completion of regulatory affairs internship, the person will have more command over the subject and get a clear idea of the various tasks involved in such a job. After completing ten years in the same field, the person will get recognized as a senior specialist. The constant growth and evolvement of the regulatory affairs department is leading towards increasing job opportunities for aspiring candidates.

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