Career Spotlight: Pharma Regulatory Affairs
Posted: 09/01/2010 12:00:00 AM EDT
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) and the European Union.
Regulatory affairs jobs in the UK and further afield are generally within the pharmaceutical, chemicals, biotechnology, medical devices and cosmetics industries. Organisations such as the FDA, also provide roles for those interested in working in the field.
As biotechnology plays an increasing role within drug development and the pharmaceutical industry, growing numbers of biotech regulatory affairs positions are opening up. Inspection of biotechnology facilities requires a high level of technical knowledge due to the ever advancing systems being used.
Pharma regulatory affairs jobs
Professionals working in pharmaceutical regulatory affairs roles will be required to handle a number of different tasks; from keeping on top of the latest developments within the industry to writing product labels and patent information.
As well as collecting and collating large amounts of information and preparing licensing submissions, pharma regulatory affairs jobs also include liaising with doctors and scientists, conducting clinical trials and negotiating with regulatory authorities.
Workers may also be tasked with undertaking and managing regulatory inspections within the company and reviewing practices when required to meet with new or updated regulatory requirements.
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.
The international scope of many companies working within the pharmaceutical industry mean that a second language is generally desirable, as it previous work experience within a clinical or pharma setting.
Pharma regulatory affairs jobs in India
Asia has emerged as a strong growth region for the pharmaceutical industry in recent years, in particular India which is fast becoming a preferred location for clinical trials and research and development activities.
The creation of a new product patent system in 2005 was a driver of this growth, which is expected to increase as the domestic market in India further opens up.
This growth has also helped facilitate an increasing number of pharma regulatory affairs jobs in India. A number of companies have set up in the most populous city in the country, creating a number of regulatory affairs jobs in Mumbai.
Figures from a companiesandmarkets.com report show that by the year 2012 the market for clinical trials in India is expected to grow to $630 million (£404 million), helped by the fact that the cost of conducting research in the country is sometimes less than half that in more developed nations.
The United Arab Emirates (UAE) is another country looking to expand its appeal to the pharmaceutical industry, increasing the number of pharma regulatory affairs jobs in Dubai.
A report by RNCOS suggests that compound annual growth of 17 per cent will take place between 2010 and 2013 and that the UAE is ripe for investment for pharmaceutical manufacturing operations.
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