Indian pharma industry is now scouting for talent in the regulatory departments as vacancies at mid and senior levels pose a continuing challenge. The workforce here needs to manage the necessary protocols to get newer submissions to health authorities and comply with the increasingly complex regulations across various markets.
According to Prakash HS, vice president – pharma & life sciences, WalkWater Talent Advisors, “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. A senior talent requires extensive technical and product knowledge of medical product development as well as knowledge of US FDA regulations. This cannot be gained without specific training and 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.
There is a shortage of experienced & skilled regulatory affairs professionals in the pharma industry. It takes many years of work experience in regulatory affairs function to understand the nuances and requirement of regulatory bodies of different countries and the process of approvals. Hiring the right individuals in the first place is an important step toward retaining the best talent which will result in lower turnover in the future. Hence the importance of running a highly mature recruiting process is important for attracting the right talent for the regulatory affairs function, Prakash told Pharmabiz in an email.
Post-Covid, regulatory bodies like US FDA, UK MHRA have been updating the guidelines regularly with respect to product safety and compliance. The individuals in the regulatory affairs function need to be updated on the ever evolving changes in the regulatory affairs landscape. They will play a major role in managing the plant inspections and getting the approval without any warnings, he said.
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.
Source: PHARMABIZ