The role of a drug regulatory affairs professional has exceeded beyond just enforcing
rules and regulations to ensuring that those rules and regulations are followed
accurately and offences are dealt with firmly. The job of the drug regulatory affairs
officer usually found at every level and there is a high demand of professionals
in this field. Professionals with both educational as well as professional background
in healthcare, life skills management, and sociology. The maintenance of the regulations
already formulated and the formulation of new regulations if necessary are some
of the job requirements.
A minimum qualification of an Honors undergraduate degree is important for a career
in Drug Regulatory Affairs and should have studied subjects in the Science stream
like Physics, Chemistry, Biology and Mathematics. Besides these, the other options
include Bio Sciences like Biotechnology, Bio Chemistry and Life Sciences. Pharmacy
is also another subject that leads to a career in Drug Regulatory Affairs. Having
a Postgraduate degree or Research experiences is an added advantage.
Required Skills for a career in Drug Regulatory Affairs
- Problem solving, analytical and decision making skills
- Ability to grasp and assimilate data
- Communication and interactive skills.
- Adhere to deadlines
- An in-depth knowledge of rules and regulations and identify areas of violation
- Needs to be Tech-Savvy and have high IT skills
- Team management skills, leadership qualities and must have Team spirit
- Negotiation skills using diplomacy.
- Fluency in English and at least one or more languages
How to become a Professional in Drug Regulatory Affairs?
There are many establishments that offer training that leads to a profession in
Drug Regulatory Affairs. By undertaking this training it is possible to land a career
in the field. Besides, it is always possible to land a job when there are requirements,
but only with the right qualification. Taking up any job in the Drug Regulatory
Affairs department can also help you break into the department at some point of
time after gaining a few years of experience.
One of the most important duties that this role has, is to ensure that the process
of licensing, especially in the health care department like pharmacy and institutions
offering medical treatment are doing so in complete compliance with the rules and
regulations as per the law of the land. The compliance should also be within the
purview of not only the legal aspects, but also that of the efficacy of the services
as well as the products and the security of the same. Scientific and technological
compliance are also checked. The officials also offer advice on the registration
process, coordinate to make the process simple and hassle free.
There is a huge demand in the field of Drug Regulatory Affairs for the professionals
and experts who are extremely familiar with the law of the land regarding medical
and health products. There is ample opportunity in most of the other industries
apart from the medical and pharmaceutical industries.
Since this is a job in great demand the salary structure is very lucrative and the
professionals and experts in this field are very highly paid.