Indian Pharma is on the lookout for Regulatory Talent, as Vacancies at the Mid and Senior Levels remains a Challenge

The Indian pharmaceutical industry is now looking for talent in regulatory departments, as vacancies at the mid and senior levels continue to be a challenge. The workforce here is responsible for managing the protocols required to submit newer submissions to health authorities and to comply with the increasingly complex regulations across various markets.

"A strong regulatory team in the company allows both faster progress towards commercialisation of products and fewer encounters with issues of non-compliance, giving companies a competitive advantage," says Prakash HS, vice president pharma & life sciences, WalkWater Talent Advisors. A senior talent must have extensive technical and product knowledge of medical product development, as well as familiarity with US FDA regulations. This is not possible without specialised training and on-the-job experience."

To facilitate the growth of the Indian pharma, the regulatory affairs function in the pharma organizations will play a major role and the importance of this function has gone up significantly over the last few years, he added. Moreover, we see the regulatory affairs function is facing a massive change as it is expected to rapidly digitize and transform the organization. Pharma companies opt for candidates with Master’s degree in pharmacy while hiring for regulatory affairs function at the entry levels roles. For mid and senior levels along with the Master’s degree, companies expect the candidates to have in-depth knowledge and experience in regulatory submissions, product registrations and complete understanding of the guidelines of each regulatory body be it US FDA, UK MHRA, etc.

Following Covid, regulatory bodies such as the US FDA and the UK MHRA have been regularly updating product safety and compliance guidelines. Individuals in the regulatory affairs function must stay current on the ever-changing regulatory affairs landscape. They will play a significant role in managing plant inspections and obtaining approval without any warnings, he stated. Hence identifying the talent who not only has in-depth technical knowledge but also has deep insights of the newer guidelines and brings in good network with the regulators will be a key challenge in hiring. In addition, it is important to look for talent which has the ability to adapt to new digital technologies and can integrate this into their core processes, said Prakash.