Regulatory Affairs
Regulatory Affairs is
a comparatively new profession which has developed from the desire of
governments to protect public health, by controlling the safety and efficacy of
products in areas including pharmaceuticals, veterinary medicines, medical
devices, pesticides, agrochemicals, cosmetics and complementary, medicines.
The companies responsible for the discovery, testing, manufacture and marketing
of these products also want to ensure that they supply products that are safe
and make a worthwhile contribution to public health and welfare. Most
companies, whether they are major multinational pharmaceutical corporations or
small, innovative biotechnology companies, have specialist departments of
Regulatory Affairs professionals – and those who don’t, rely on the expert
advice of independent regulatory consultants to meet their obligations.
The Regulatory Affairs professional’s job is to keep track of the ever-changing
legislation in all the regions in which the company wishes to distribute its
products. They also advise on the legal and scientific restraints and
requirements, and collect, collate, and evaluate the scientific data that their
research and development colleagues are generating.
They are responsible for the presentation of registration documents to
regulatory agencies, and carry out all the subsequent negotiations necessary to
obtain and maintain marketing authorisation for the products concerned.
They give strategic and technical advice at the highest level in their
companies, right from the beginning of the development of a product, making an
important contribution both commercially and scientifically to the success of a
development programme and the company as a whole It may take anything up to 15
years to develop and launch a new pharmaceutical product and many problems may
arise in the process of scientific development and because of a changing
regulatory environment. Regulatory Affairs professionals help the company avoid
problems caused by badly kept records, inappropriate scientific thinking or
poor presentation of data. In most product areas where regulatory requirements
are imposed, restrictions are also placed upon the claims which can be made for
the product on labelling or
The Regulatory Affairs department will take part in the development of the
product marketing concepts and is usually required to approve packaging and
advertising before it is used commercially. Many companies operating in the
high-technology health-care and related industries operate on a multinational
basis and are very significant exporters.Their Regulatory Affairs departments
must be aware of the regulatory requirements in all the company’s export
markets.
As an added complication, despite recent international efforts towards
harmonisation of requirements, the regulations laid down by different
governments and their interpretation by the regulatory agencies, rarely match.
Consequently, the registration data prepared for one country frequently fail to
meet the requirements for another. Therefore great care has to be taken in
drawing up efficient and economical research and development programmes whose
results may be used as widely as possible. Regulatory Affairs professionals,
with their detailed knowledge of the regulations and guidelines, are frequently
called in to advise on such matters.
why is regulatory affair is important
In today’s competitive environment the reduction of the time taken to reach the
market is critical to a product’s and hence the company’s success.The proper
conduct of its Regulatory Affairs activities is therefore of considerable
economic importance for the company.
Inadequate reporting of data may prevent a timely positive evaluation of a
marketing application. A new drug may have cost many millions of pounds, Euros
or dollars to develop and even a three-month delay in bringing it to the market
has considerable financial considerations. Even worse, failures to fully report
all the available data, or the release of product bearing incorrect labelling,
may easily result in the need for a product recall. Either occurrence may lead
to the loss of several millions of units of sales, not to mention the resulting
reduction in confidence of the investors, health professionals and patients.
A good Regulatory Affairs professional will have a ‘right first time’ approach
and will play a very important part in coordinating scientific endeavour with
regulatory demands throughout the life of the product, helping to maximise the
cost-effective use of the companysresources.
The Regulatory Affairs
department is very often the first point of contact between the government
authorities and the company.The attitudes and actions of the Regulatory Affairs
professionals will condition the perceptions of the government officials to the
company -for better, or for worse! Officials respond much better to a company
whose representatives are scientifically accurate and knowledgeable than to one
in which these qualities are absent.
The importance of the Regulatory Affairs function is such that senior
Regulatory Affairs professionals are increasingly being appointed to boardroom
positions, where they can advise upon and further influence the strategic
decisions of their companies.
How do Regulatory Affairs professionals relate to other professionals?
The very nature of the task to be done brings regulatory personnel into contact
with almost every discipline within the industry. This may include scientists
such as pharmacologists, toxicologists, analytical chemists, pharmacists,
medical doctors, veterinarians, engineers, physical chemists and statisticians.
That being said, the work is by no means confined to science but extends to the
interface with and appreciation of advertising,marketing,legal,patent and
manufacturing skills.
An ability to liaise closely with every kind of specialist is a crucial part of
the job. Not only must there be the ability to use and assimilate information
provided by such specialists, but also to present that information to
regulatory authorities and feed-back their opinions to the rest of the company
and appraise staff about the current thinking of the regulatory bodies.
In short, the regulatory specialist is central to the business and has the
opportunity to interact with a wide range of specialities and extend his or her
knowledge while doing so.
What makes a good Regulatory Affairs professional?
Most regulatory professionals are graduates in a scientific discipline –
commonly life sciences or pharmacy – although increasingly biotechnology-based
degrees are valuable. Some choose to have an additional legal qualification,
and TOPRA offers an MSc in Regulatory Affairs for those who wish to gain a
formal professional qualification in the discipline.The ability to tackle data
in a wide range of scientific areas and to quickly grasp new concepts and
complex technical information is vital.
Communication skills are very important.Analysing issues and presenting both
written and oral evidence before a panel of experts such as scientists,
pharmacists, doctors and lawyers who run the government agencies require
considerable understanding of both legal and scientific matters. An attention
to detail is a pre-requisite.
An analytical frame of mind is important,too. An ability to evaluate the
strengths and weaknesses of the technical and legal options open to a company
and to the agency concerned is crucial.
A high degree of sensitivity is required when proposing and executing the
strategy and tactics needed to obtain marketing approval in a way which will
satisfy the authorities and serve the best needs of the company.
Considerable care must be exercised if the best possible case is to be
presented to the authorities for the company. It must be done without obscuring
the facts, enabling the authorities to arrive at a proper and rightful conclusion
regarding safety, efficacy and quality of the product under application.
Regulatory professionals must always exercise considerable judgement in the
practice of their role. Integrity and the ability to inspire trust and
confidence are valuable attributes.
Good regulatory people ‘make it happen’. Project management skills help to
achieve the challenging goals they are set.They can work as part of
multi-disciplinary teams and lead them when necessary.They can work under
pressure and inspire and motivate others to do the same.
Regulatory Affairs is an important and exciting profession. Find out more by
contacting the TOPRA office.
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 Career in Pharma Regulatory Affairs
(DRA)
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.
