REGULATORY AFFAIRS - A GREAT CAREER OPPORTUNITY.

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.

Avoiding problems :

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.