Dr. Shuvankar Ballav Shares Career Insights And The Evolving Role Of Regulatory Affairs In Biopharma On Pharma Now

Mumbai, Maharashtra, India — In a candid and thought-provoking video interview with Pharma Now, Dr. Shuvankar Ballav, a seasoned leader in regulatory affairs, shared his professional journey and deep insights into the biopharmaceutical and biosimilar industries. Tracing his path from a student in Kolkata who once aspired to become a doctor and scientist, Dr. Ballav revealed how his academic background in biotechnology and years of research including a PhD and postdoctoral fellowships shaped his scientific foundation before he transitioned into the pharmaceutical industry. Today, he serves as the Head of Regulatory Affairs at IPCA Laboratories, where he leads global regulatory strategy and compliance.

Dr. Ballav explained that shifting from academia to industry was not without its challenges. Despite having strong research credentials, he had to adapt to the pace and practical demands of the pharmaceutical business, an environment that required both technical expertise and operational agility. He delved into the complexities of regulatory roles, especially the critical differences between biosimilars, which are large molecule biologics, and traditional small molecule drugs. Biosimilars, he noted, involve more intricate data, rigorous comparability studies, and close coordination with global agencies like the US FDA, EMA, and CDSCO. 

He also unpacked regulatory compliance frameworks, including GMP (Good Manufacturing Practice), FDA 483 observations, and warning letters, explaining how these should be seen as opportunities to improve systems rather than as failures. A core theme of the discussion was the cross-functional nature of regulatory affairs. Dr. Ballav described regulatory professionals as integrators, individuals who work closely with quality assurance, manufacturing, R&D, legal, and project management teams. Their role involves ensuring that submission timelines are met, documentation is accurate, and products align with global safety and efficacy standards. 

Effective communication, trust-building, and structured planning, he emphasized, are essential leadership traits in regulatory affairs. The conversation also addressed the growing influence of artificial intelligence (AI) in regulatory workflows. Dr. Ballav acknowledged AI’s potential to speed up data processing, streamline query responses, and support regulatory intelligence. However, he cautioned that AI should be used as an enabler, not a replacement, for domain expertise. Validation by experienced professionals remains essential, especially since regulatory authorities expect AI tools to be supported by proof-of-concept data and detailed documentation before full-scale adoption.

Throughout the video, Dr. Ballav underscored the importance of maintaining a positive, growth-oriented mindset—particularly when facing regulatory challenges like audits or compliance observations. These, he said, offer valuable opportunities to enhance internal systems, improve operational quality, and ultimately ensure patient safety. He encouraged regulatory professionals to approach their roles as ongoing learning journeys, staying up to date with changing regulations, new technologies, and industry best practices.

The interview concluded with a rapid-fire session where Dr. Ballav shared his leadership philosophy: balance speed and accuracy, stay energized, communicate effectively, and never stop learning. He offered heartfelt advice to aspiring professionals in regulatory affairs, urging them to embrace adaptability, view problems as learning opportunities, and cultivate curiosity beyond the regulatory domain including areas like market trends, business development, and AI.

To watch the full podcast and gain insights from Dr. Shuvankar Ballav's incredible views on regulatory affairs in the pharma industry, learn
GMP, 483s, and Warning Letters: What Ipca’s Regulatory Affairs Head Wants You to Know