Regulatory Affairs Upskilling and Job Opportunities

As per NITI Ayog's “Investment Opportunities in India’s Healthcare Sector” 2021 report, Healthcare has become one of the largest sectors of the Indian economy, in terms of revenue as well as employment. The sector has been growing at a CAGR of 22% since 2016 and India's domestic Pharma market is estimated to reach $130 billion by 2030.  

India Briefing reported that India's healthcare ecosystem is amongst the fastest-growing sectors due to government policies and efforts to make the country a global hub for health and wellness. There is a huge influence of foreign investment in this area due to a liberalized FDI regime in various sub-sectors like hospitals, medical devices, health insurance, etc.

Regulatory affairs (RA) is gaining importance globally in view of evolving regulations, growing quality concerns, and globalisation of business operations. Thus, the industry is experiencing explosive growth and facing a deficit of trained professionals in the field. Further discovery, development, and commercialisation of new products is a long and complicated process that requires a skilled workforce and careful planning; consequently, there is increased demand for RA specialists.

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Regulated sectors like pharmaceutical, life sciences, medical technology (MedTech), food, clinical research and healthcare industries require Regulatory Affairs professionals with appropriate backgrounds to successfully run their operations.  

Potential for consistent growth, industry shortage of qualified talent, a wide range of flexible career options, a wide range of transferrable skills, and the ability to accommodate professionals form wide knowledge domain make regulatory affairs an attractive career choice.  

Regulatory Affairs as Career Option: As these industries are evolving there is a growing need for a workforce in regulatory affairs. Biospace recently published the latest global Regulatory Affairs Outsourcing market report, expected to reach beyond US$ 12.9 billion by 2030 and is anticipated to grow at a CAGR of 8.5% between the forecast period 2021 to 2030. Current trends reveal that fresh Pharma Regulatory Affairs specialists can earn starting median annual salary in India in the range of 2.75 to 3.75 lakhs.  Working professionals from various industries such as medical and dental devices, in vitro diagnostics (IVDs), food, herbals, microbiology, dietary supplements/nutraceuticals, cosmetics, molecular biology, and veterinary sciences, willing to switch career to regulatory affairs can earn 3.5 – 4.5 lakhs per annum.        

Domain knowledge and core skills such as leadership, communication, keeping up with the rules and regulations, problem-solving, quick learning, consistency, exploring mindset, and accurate decision-making is essential for success in Regulatory Affairs.

One of such programs which stands out among various program offered by universities is the Post Graduate Diploma in Regulatory Affairs (PGDRA) by the School of Health Sciences and Technology (SoHT), Dr Vishwanath Karad MIT World Peace University (MIT WPU), Pune.  Curriculum consists of global regulatory affairs, clinical research regulations, regulatory aspects of drugs and cosmetics, biologicals medical devices and in vitro diagnostics regulation, regulatory aspects of herbals and nutraceuticals, and   eCTD hands on training. The program focuses on explicit training and has capstone project. The program provides recent, relevant and in-depth knowledge and skills to cross high entry barriers to RA field. Corporate RA domain experts are involved to deliver the program contents. 

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