REGULATORY AFFAIRS - A GREAT CAREER OPPORTUNITY:
Regulatory affairs is a comparatively new profession which 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.
A new class of professionals emerged to handle these regulatory matters for
companies.
The regulatory professional :
A regulatory professional is responsible for keeping track of the
ever-changing legislation in all the regions in which a company wishes to
distribute its products, advise on the legal and scientific restraints and
requirements, and collect, collate and evaluate scientific data.
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 takes 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 professionals help
the company avoid problems caused by badly kept records, inappropriate
scientific thinking or poor presentation of data.
Marketing and advertising :
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 in advertising.
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.
Working internationally :
Many companies operating in high-technology healthcare and related
industries operate on a multinational basis and are significant exporters.
Their regulatory affairs departments must be aware of the regulatory
requirements in all the company’s export markets.
Despite recent international efforts towards harmonisation of requirements,
the regulations laid down by different governments and their interpretation by
the regulatory agencies rarely match. 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 professionals, with their detailed knowledge of the regulations and
guidelines, are frequently called in to advise on such matters.
Healthcare RA
:
The regulatory function in healthcare
industries is vital in making safe and effective healthcare products available
worldwide. Individuals who ensure regulatory compliance and prepare
submissions, as well as those whose main job function is clinical affairs or
quality assurance are all considered regulatory professionals.
Regulatory professionals are employed
in industry, government and academia and are involved with a wide range of
products, including:
·
pharmaceuticals
·
medical devices
·
in vitro diagnostics
·
biologics and biotechnology
·
nutritional products
·
cosmetics
·
veterinary products
The regulatory professional's roles and responsibilities often begin in the
research and development phases, moving into clinical trials and extending
through premarket approvals, manufacturing, labeling and advertising and post
marketing surveillance.
Core competencies :
Regulatory professionals come from
diverse backgrounds. Most regulatory professionals have earned a bachelor's
degree, and more than half have an advanced degree, most often in a scientific
or technical field. In addition, regulatory professionals usually have
experience in other careers before transitioning into regulatory affairs.
Although there are some university
degree and graduate certificate programs in regulatory affairs and related
areas, experience is a key asset for regulatory professionals. Valuable skills
include project management and organization, negotiation and communication, and
the ability to learn from the experience of others, both inside and outside the
organization.
Continuing education and professional
development are critical to the regulatory professional. Regulatory
professionals must keep up to date with regulatory policies and procedures for
one or more countries, as well as maintain an understanding of the scientific
and technical background of healthcare products. Global aspects of regulatory
affairs are taken up by organisations such as the Drug Information
Association (DIA) and the International Conference on Harmonisation
of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
Future developments :
Many in the Regulatory Affairs
Profession believe the New Approach to regulation will eventually be adopted
for all healthcare products as it represents the best model for delivering new
healthcare advances to market in a reasonable time with acceptable safety.
Regulatory Affairs departments are
growing within companies. Due to the changing resources necessary to fulfill
the regulatory requirements, some companies also choose to outsource or outtask
regulatory affairs to external service providers. Regulatory Affairs department
is constantly evolving and growing and is the one which is least impacted
during the Acquisition and Merger, and also during recession. Global harmonization
in standards has led to consistent approach in regulatory submissions and hence
its review.