Pharma regulatory affairs professionals
play an essential role in ensuring all pharmaceutical products comply with
regulations governing the industry.
Those working in pharma regulatory affairs
jobs not only work in the initial application phase for a new or generic drug,
but also in the licensing and marketing stages – making sure all operations and
products meet required safety and efficacy standards.
Professionals must combine knowledge of the
business, legal and pharmaceutical industries to determine if regulations are
being followed and in many cases form the link between pharma companies and
regulatory authorities, such as the Food and Drugs Agency (FDA), FSSAI Consultant in India and the European
Union.
There are different types of education a
student can choose from, depending on their interest and skills. Students can
start from Diploma to PhDs.
Students find employment in the following
industries/sectors:-Drugs, Pharmaceuticals & Bio-pharma, Medical devices
& equipment manufacturing, Cosmetics & Perfumes, Regulatory Affairs
(Food & Drug Control Administration appointed by the government and
Regulatory Affairs Depts., in companies), Patents, trademarks and IPR
(Documentation department in government and private companies), Pharma journalism
(Media editorial team), Blood banks, FSSAI,Consultancies
- offering varied services. (Regulatory affairs, documentation, research,
manufacturing, survey and analysis, information retrieval, data management,
turn key projects etc.)
Opportunities for regulatory affairs
consultants offer professionals the chance to work in a number of fields, which
requires high levels of knowledge of multiple industries.
Jobs in pharma regulatory affairs generally require a background in the
applicable industry, business knowledge, great oral and written communication,
good attention to detail and strong IT skills.
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