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 are 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.