RA is
an industry that oversees how foods, drugs, and medical products are developed,
tested, manufactured, marketed, and distributed to certify that they meet
regulatory standards for human use. RA
department of a pharmaceutical company is responsible for obtaining approval
for new pharmaceutical products and ensuring that approval is maintained for as
long as the company wants to keep the product on the market. RA professionals
are responsible for ensuring manufacturers’ compliance with applicable global
legislative and regulatory requirements at each stage of product development.
In the drug, medical device, and biologic product industries, these phases
include: research and development, clinical trials, regulatory submissions,
manufacturing, marketing, distribution, reimbursement, and post-market
surveillance. In the food industries, regulatory professionals engage with
products, facilities, manufacturing operations, and distributors along the farm-to-fork
lifecycle.
These regulatory professionals play
a critical role in the development and distribution of medical technological
advancements and drugs, disease-free food, improving people’s health and
welfare around the world.
What’s the Job Outlook
and Market Demand?
As the RA discipline plays an integral role in medicicne, global health,
food safety, and medical innovation, it’s no surprise that the job market is
growing. In 2016, the U.S. regulatory market experienced a 42 percent increase
in job listings and the U.S. Bureau of Labor Statistics estimates the field
will continue to grow at an average rate of eight percent until 2026. As new
and developing industries become increasingly regulated, the demand for
additional and specialized regulatory expertise will increase.
But what do these
professionals actually do on a daily basis?
RA officers act as a link between companies and
regulatory authorities, ensuring that products are manufactured and distributed
in compliance with appropriate legislation. RA specialists are expected
to be extremely passionate regarding the safety and efficiency of drugs and
medical devices in the health care industry. Their interest for the sector must
be deeply grounded into their function. This role demands expertise in a few
distinct areas to be able to become successful. The role includes
gathering, evaluating, organizing, managing and collating
information in a variety of formats/
ensuring compliance with
regulations set by the Medicines and Healthcare products Regulatory Agency
(MHRA), different regulatory bodies such as the
Food and Drug
Administration (FDA or
USFDA),
Health Science Authority or HSA, the
Singaporean regulatory agency,
European Medicines Agency (EMA) etc. Some major responsibilities
of professionals working in regulatory affairs departments are:
– Formulating a drug development strategies
– Providing regulatory consultation
– Conducting gap analysis
– Developing product dossiers and their submission to applicable regulatory agencies
– Communicating with regulatory agencies
– Providing regulatory affairs related training to applicable team members
and/or departments
Ever since the field
of pharmaceutical drug development, manufacturing and marketing became
regulated by regulatory agencies such as the US FDA, EMEA, MHRA etc, the area
of Regulatory Affairs has opened up new opportunities of employment. The growth
of the clinical research industry has pushed this demand for skilled regulatory
affairs professionals even further. Regulatory Affairs careers in clinical
research are very satisfying and exciting as the regulatory function is vital
in making safe and effective healthcare products available worldwide. Roles and
responsibilities of regulatory professionals often begin in the research and
development phases for each product and continue throughout the product life
cycle. Regulatory Affairs professionals keep themselves updated with global and
local regulatory policies, procedures and trends. They also maintain
understanding of scientific and technical background of healthcare products.
Regulatory affairs department adds great value to drug development worldwide by
comprehending and interpreting the regulatory environment and suggesting
pathways for reducing the time to market.
How much do these
RA professionals earn?
An entry-level Regulatory Affairs Specialist with
less than 1 year experience can expect to earn an average total compensation
(includes tips, bonus, and overtime pay) of ₹307K. An early career Regulatory
Affairs Specialist with 1-4 years of experience earns an average total compensation
of ₹386K. A mid-career Regulatory Affairs Specialist with 5-9 years of
experience earns an average total compensation of ₹615K. An experienced
Regulatory Affairs Specialist with 10-19 years of experience earns an average
total compensation of ₹808K.
About the course and
the programme at Dysmech Clinical Services Pvt Ltd (DCS)
For regulatory affairs careers in clinical
research and in the pharmaceutical industry at large one can undergo Advanced and Diploma courses in
Regulatory Affairs and Clinical Research courses in Pune. DCS offers 1 year Advanced and Post Graduate Diploma in Clinical
Research and Regulatory Affairs.
Anyone prefers to be in Clinical research industry and medical profession can
undergo for this programme for detailed knowledge on the same. The main intent
of the course is to develop clinical research and RA professionals who are
equipped with the most relevant and up to date knowledge and skills. Clinical
research and RA training programme is practically driven and centered on the
tasks expected of a RA professional in the clinical research industry. In this
RA training we provide you with the understanding of the global regulatory
structure and acquire skills needed for regulatory strategic planning
throughout the life cycle.
About DCS
DCS is an educational, training and soft skill
development organization. It is the centre for skill and entrepreneurship
development in clinical research industry offering excellent platform and
knowledge to land into a good company or enterprise and can boost their growth
opportunities by availing the benefits of our wide network and contacts across
the companies and industries.
Our company provides best and state of art
facilities and knowledge sharing platforms which is an exception in the
Industry.DCS offers specialized programs with industry exposure in
international standards with Drug information Association (DIA) courses in Pune
from experts and top professionals of the same industry itself having a rich
experience and exposure on the technologies in the Clinical research industry.
So, when are you, joining??
Check out the details and contact us today to be
leader of tomorrow.
