To empower the Professionals community with knowledge of Pharma as to provide the platform & opportunity to the young minds to enter the world of R&D sector of Pharma Industry.

Thursday, February 9, 2012

Career Spotlight: Pharma Regulatory Affairs

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.

Pharma Regulatory Affairs

Pharma Regulatory Affairs (12 Months Program)


The industry program aims to prepare aspirants for regulatory affairs positions in the pharmaceutical, biopharmaceutical and medical device industries i.e. to equip them with the educational foundation that will help them advance in the regulatory affairs profession. The course will provide the student with the fundamentals required in both regulatory affairs and quality operations. This course is designed to give industry level education in field of legal and regulatory issues. These issues are very critical to Pharma companies, Clinical Research Organization, Bio Tech companies. The course focuses on regulatory affairs concept which the Pharma companies must comply to sell their drugs both domestically and in the international market.

The course has been framed with the following objectives
  • To decipher a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical and medical device products.
  • To create experts in the field of RA documentation and research
  • To help students build their career in RA and become RA professionals.
  • To provide students with a global knowledge of Regulatory Affairs.
Career Opportunities

As regulatory processes increase in complexity and scope, and globalization occurs within the field, there will be continuing industry demand for people with a strong foundation in regulatory affairs. The students of the program will have an understanding of the regulatory processes involved in biotechnology, medical device, pharmaceutical and food products. Students will become eligible for occupations involving drug or medical device submissions and quality assurance functions and roles. The individuals who are interested in pursuing a career in regulatory affairs would get a thorough understanding of current regulations and their application to the development and commercialization of drug, biologic and biodevice products. The Regulatory Affairs program provides professionals with the specialized knowledge required to help biotechnology, medical device, pharmaceutical and food companies manage regulatory processes. The course would facilitate the participants with the understanding of th e areas of regulatory affairs and quality operations to give students a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical and medical device products.

  • Pharma Regulatory Affairs Consultant
  • Regulatory Officer

For further details and enquiries
Call:0120-4320801/02
Mob:09810535368,9818473366
E-mail : info@bii.in,