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.
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.
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.
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.
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.
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)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 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
Pharma
regulatory affairs jobs in India
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.
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.
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