Dr. Nirdosh Jagota: Mastering the Pharmaceutical Landscape Through Regulatory Expertise

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Dr. Nirdosh Jagota: Mastering the Pharmaceutical Landscape Through Regulatory Expertise Jon Stojan Contributor Published 1:27 p.m. ET Jan. 23, 2024

What does it take to successfully roll out new medications in today’s complex regulatory environment? To get a closer look, we spoke with Dr. Nirdosh Jagota, a pharmaceutical consultant with GRQ Biotech Advisors. Dr. Jagota’s pharmaceutical research and manufacturing career highlights include cancer, Ebola, COVID, and anti-depressant therapies that opened new markets, and helped to achieve billions in sales world-wide.

With stops at Merck, Pfizer, Squibb, Sanofi, and Roche over the course of his extensive career, Dr. Jagota has proven himself to be a problem solver, overcoming obstacles in research and development, streamlining complex regulatory processes, improving employee engagement levels, and nurturing understanding in multi-cultural organizations. To learn more about his professional journey, visit his LinkedIn profile.

During our discussion last week, we asked Dr. Jagota to highlight some of his experiences and to provide insights that may prove valuable for up-and-coming pharma executives. Some excerpts follow:

Navigating the Regulatory Environment “When it comes to regulatory bodies such as the FDA and EMA”, began Dr. Jagota, “it is important to realize that regulators are human beings, with their own needs, ideas, and knowledge. In order to foster cooperation, it is important to make them partners in the project, and to credit them as such.”

Throughout our talk, Dr. Jagota emphasized the need to streamline the regulatory process, and told us of some of his efforts in this regard. “During my time at Pfizer (formerly Wyeth),

we established the first global center for 24/7 clinical study report writing – with the intention of speeding up daily reporting tasks, as well as the entire FDA approval process.”

“At Pfizer, we became the first among the early adapters to implement the FDA’s Quality-byDesign program. The FDA’s approval of our program allowed us to simplify change management. You see, even minor changes to a manufacturing process – including the packaging – require a filing with the regulators, making us vulnerable to supply-chain dynamics. In order to mitigate this risk, we developed an FDA-approved compatibility protocol for product changes that enabled quick scale-ups and site changes for mass product distribution.”

“Our compatibility protocol concept succeeded in streamlining the FDA and EMA approval processes, and was adopted by other regulators and pharmaceutical companies world-wide.”

Fostering the Leadership Pipeline “Leadership development has always been a priority of mine,” said Dr. Jagota. “In one of my roles, I was tasked with leading a multi-national team involving 800 employees in 35 countries – most of them Ph.D.s and M.D.s.

Regarding the empowerment of personnel, Dr. Jagota explained his approach: “I’m proud to say that so many of my team members have moved on to senior positions in the pharma sector. My goal, as their mentor, was to develop and leverage their existing talents, while providing them with opportunities for further advancement.”

“I would constantly challenge my team members, asking pointed questions, while providing them with the freedom and security to take informed risks without the consequences of failure. Of course, I’d be quietly watching them – in order to catch mistakes and prevent failures – enabling them to avoid failures and develop the confidence they would need as future leaders. In addition, I made efforts to increase staff engagement by giving them credit both for ideas and their implementation. A good example of this can be seen from my time at one of the companies, where average employee engagement scores improved from 36% to 68%.”

“In turn, I encourage team leaders to extend the company’s leadership pipeline through effective coaching of their own staff members. This approach is not just relevant for superstars and high-performers, but for every employee – leading to sustainable, grass-roots

organizational development. Everyone should be encouraged to contribute and suggest solutions.”

Easing the Post-Merger Culture Clash In these days of corporate consolidation, mergers inevitably require the amalgamation of teams from different cultures with distinctly different work ethics. Getting these teams to work in a harmonious and cooperative fashion can be a difficult challenge. Dr. Jagota, a U.S. citizen who spent three years living and working in Europe, described one such episode from the merger between a European company and a US-based company.

“Senior managers from the US were nominated to lead projects that included teams from Europe. From the start, the contrasts were blatant. The European guys, in their white shirts and ties, were suddenly reporting to American managers in their t-shirts and jeans. But the dress code was only a symptom of a much deeper cultural divide…”

“The Americans tended to work through their lunch hour – a social event that is a fundamental part of the European work day. They often worked late into the evening as well, but didn’t realize that in Europe, child care centers rarely offer services after 6PM. Given the time difference, the Americans were limited to early-morning conferences.”

“So we had to do a bit of cross-cultural sensitivity training. Lunch-hour meetings were out.

Late evening conferences were held only when unavoidable. In addition, we created four homogenous sub-teams. Each sub-team would report to management, which provided balance and coordination when necessary.”

“The decision-making processes were different as well. On the European side, teams were fully empowered to take control of projects, with minimal management intervention. Of course, mistakes were made, but the teams had the freedom to move quickly. In the US, on the other hand, management was more heavily involved, providing input and validating decisions – requiring European teams to delay progress as they spent more time preparing presentations. So a compromise was found, in which we defined boundaries within which teams could operate autonomously. Only issues outside the boundaries required management approval. This allowed us to reduce the number of review committees and keep projects on the fast track.”

In Summary Today, as managing partner of the GRQ Biotech Advisors pharma consultancy, Dr. Jagota provides pharmaceutical companies with advisory services in his primary areas of expertise – product development, regulatory, and quality management.

Concluded Dr. Jagota, “As a guiding principle, we must constantly remind ourselves to put the patient’s needs first. In our industry, it’s the only sustainable path to success.”Dr. Jagota can be contacted at nirdoshjagota@gmail.com.

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