Indian & MNC pharma cos scout for qualified pharmacy graduates & post graduates to work in regulatory depts
Regulatory departments of domestic and
multinational companies in the country along with and drug control departments
and start-up enterprises are scouting for qualified pharmacy graduates and post
graduates, said Dr. Shenaz Khaleeli,
founder and technical director, PharmaLeaf India.
The key reason, according to Dr. Khaleeli, is
that regulatory affairs has evolved in India. “The country is looking to build its efficiency in this space.
Regulatory operations require expertise across products, therapeutic areas and
global markets. Therefore pharmacy graduates and post graduates can consider
this field as a promising career growth path”, she added.
Speaking at the pre-conference inauguration
of the three-day Alfacon 2017 organised by the Al-Ameen College of Pharmacy in
Bengaluru which is being held from February 9-11, Dr. Khaleeli, said “Drug life cycle management, R&D
commercialisation , post approval compliance require regulatory services. There
is a need for dedicated and qualified pharmacy workforce.”
The high cost of new biological drug
development sees pharma giants collaborate to maintain compliances from
research to clinical trials and post market surveillance. The bar for high
standards and norms is only going to increase. There is need for data driven
compliance and we are witnessing a huge demand and supply in technical and
business pharma functions. There is need for the team work because regulatory
service is a powerful tool to ensure safety, efficacy and affordability of
drugs, she pointed out.
Every country is building the capability and
capacity of international standards. There are promising career avenues where
the prospective candidates will focus on regulatory approvals spanning from
drug filing strategy, dossier submissions and training. We also see technology
as a strong enabler to connectivity. This calls for a pool of expertise in
technical writing and electronic common technical document (eCTD) to companies
to transmit regulatory data, said Dr. Khaleeli.
Moreover, use of information technology (IT)
pervades across supply chain management and pharmacovigilance. Now
pharmaceuticals is a knowledge driven sector. There is ample scope for
employment in big data mining, tracking market trends, and analytics. In
addition, the central and state drugs control departments also need enforcement
teams to inspect and regulate drug quality and monitor its pricing as per
norms. The insurance sector across the world is also insisting on high quality
and cost-effective medicines to stall prohibitive claims.
Another emerging area where specialisation in
regulatory affairs is the much sought-after Intellectual Property Rights (IPR).
In an age of incremental research, the focus is on novel efficacious drugs that
are priced for the masses. Therefore, there is a need to align people and
processes to sustain a strong regulatory system. From new biologics, stem
cells, vaccines, to nutraceuticals and herbal drugs, require intelligent
regulators. Global filing needs ample expertise. This makes Indian & MNC
pharma companies scout for qualified pharmacy graduates & post graduates to
work in regulatory departments, concluded Dr. Khaleeli.
Comments
Post a Comment