Zoher T. Sihorwala: Shaping Regulatory Strategy For Affordable, High-Quality Medicines
Zoher T. Sihorwala
Head - Global Regulatory Affairs
In an era of rapid scientific advancement and complex global markets, their role is central to ensuring that safe, effective, and affordable medicines reach patients in a timely manner.
One such leader is Zoher T. Sihorwala, currently Head – Global Regulatory Affairs at Wockhardt Limited. A firm believer in pharmacy as a noble profession dedicated to healing and enhancing quality of human life, he has spent over 25 years working to make medicines both available and affordable.
An alumnus of College of Pharmacy, SGSITS, Indore and Jamia Hamdard, New Delhi, he has built a distinguished career across research and development, quality and compliance, and project management.
His professional journey encompasses his formative years being at Piramal and Ranbaxy; his leadership roles at prominent pharmaceutical organizations such as, Zydus Cadila, Glenmark Pharmaceuticals, and Dr. Reddy’s Laboratories.
In addition to his corporate responsi -bilities, he contributes as an advisor and governing member to academic and scientific bodies, and is currently pursuing a PhD) at Manipal College of Pharmaceutical Sciences, focusing on the application of Artificial Intelligence in the pharmaceutical industry.
Recognized among leading healthcare professionals across Asia-Pacific and India, he continues to exemplify leadership in regulatory science and innovation. Let’s read.
With over 33 years of industry experience, what have been the defining milestones in your professional journey so far?
Over 33-years career my journey has evolved through two defining phases. The first decade (1993–2003) was dedicated to building a strong technical foundation in regulatory affairs, where
intensive work in compliance and remediation sharpened my attention to detail and deepened my under standing of regulations as scientific safeguards.
The subsequent 23 years have been focused on leadership, transitioning from a registration specialist to a “scientific lawyer” who interprets science through the lens of regulation and business impact. Key milestones include leading the highest number of ANDA filings for the U.S. market during 2003–2004 and securing major approvals between 2003 and 2008 that significantly contributed to business growth.
From 2008 to 2013, the focus shifted to integration and capability building, including establishing a Global Regulatory Council, driving defect-free submissions through continuous learning, and expanding expertise across Complex Generics, NCEs, and Biosimilars, broad experience that continues to shape my leadership approach.
What approach have you followed to ensure the delivery of affordable high quality medicines to patients worldwide?
I would not call it a strategy in the conventional sense; for me, it is more an etiquette of operating. In our industry, the buzzword is 'right the first time.' The real question, however, is how we truly achieve that.
Medicines exist to treat patients, and because they directly impact human life, they are rightly regulated. To make a medicine available, one must obtain the necessary licenses. Securing approvals on time ensures that patients receive access to treatment without delay. Timely approval is not just a regulatory success; it is a contribution to public health.
When we speak of medicines, quality is inherent in their very purpose. The term 'high quality' almost suggests the possibility of 'low quality,' but in our world, that distinction cannot exist.
There is no room for low quality in healthcare, because low quality equates to risk, and risk to life is unacceptable. Therefore, my approach has always been simple: build robust science, ensure compliance right the first time, and never compromise on quality, because patients’ lives depend on it.
How would you describe your leadership philosophy, and what principles guide the way you lead your teams?
My leadership approach is simple: delegate, not duplicate. I
The subsequent 23 years have been focused on leadership, transitioning from a registration specialist to a “scientific lawyer” who interprets science through the lens of regulation and business impact. Key milestones include leading the highest number of ANDA filings for the U.S. market during 2003–2004 and securing major approvals between 2003 and 2008 that significantly contributed to business growth.
My leadership approach is simple: delegate and do not duplicate. I strongly believe in empowering and collaborating
From 2008 to 2013, the focus shifted to integration and capability building, including establishing a Global Regulatory Council, driving defect-free submissions through continuous learning, and expanding expertise across Complex Generics, NCEs, and Biosimilars, broad experience that continues to shape my leadership approach.
What approach have you followed to ensure the delivery of affordable high quality medicines to patients worldwide?
I would not call it a strategy in the conventional sense; for me, it is more an etiquette of operating. In our industry, the buzzword is 'right the first time.' The real question, however, is how we truly achieve that.
Medicines exist to treat patients, and because they directly impact human life, they are rightly regulated. To make a medicine available, one must obtain the necessary licenses. Securing approvals on time ensures that patients receive access to treatment without delay. Timely approval is not just a regulatory success; it is a contribution to public health.
When we speak of medicines, quality is inherent in their very purpose. The term 'high quality' almost suggests the possibility of 'low quality,' but in our world, that distinction cannot exist.
There is no room for low quality in healthcare, because low quality equates to risk, and risk to life is unacceptable. Therefore, my approach has always been simple: build robust science, ensure compliance right the first time, and never compromise on quality, because patients’ lives depend on it.
How would you describe your leadership philosophy, and what principles guide the way you lead your teams?
My leadership approach is simple: delegate, not duplicate. I
strongly believe in empowering and collaborating. I give my team the space to plan and execute effectively within the timelines we define. I ensure they have abundant information, clarity of expectations, and access to the right technological tools and training. When people are equipped and trusted, they deliver their best.
Equally important are appreciation, recognition, and reward. As a leader, accountability rests with me. Responsibility can be delegated, but accountability cannot. That clarity strengthens trust, ownership, and performance across the team.
How do you stay current with evolving industry trends and prepare your organization for the future?
We are living in smart times, and staying current requires conscious effort. I use social media rationally selectively engaging with credible platforms for insights rather than noise. I consistently read within my area of work to deepen my scientific and regulatory understanding.
Networking within the professional fraternity also keeps me aligned with emerging perspectives and practical experiences. Above all, I value mentorship. Having mentors allows me to test my thoughts, gain wisdom from experience, and remain grounded while adapting to change.
Drawing from your long career, what guidance would you offer to emerging leaders in this field?
My first advice is to derive a clear purpose. When your work is anchored in purpose, direction becomes clearer and resilience stronger. Be sincere and stable in whatever responsibility you undertake. Depth comes from consistency, not constant movement.
Commit yourself to continuous learning - read, upgrade your knowledge, and be willing to learn, unlearn, and relearn. The industry evolves, and so must we.
Above all, do your work well. I am deeply inspired by the words of Martin Luther King Jr., who said that what ever your calling, you should perform it with excellence. Excellence in execution, no matter the role, is what ultimately defines true leadership.
Zoher T. Sihorwala, Head – Global Regulatory Affairs, Wockhardt
Zoher T. Sihorwala is Head – Global Regulatory Affairs at Wockhardt, with over 25 years in regulatory affairs. An advocate of affordable, quality medicines, he has led global filings, contributed to regulatory science, and continues Ph.D. research on AI in pharmaceuticals.
Equally important are appreciation, recognition, and reward. As a leader, accountability rests with me. Responsibility can be delegated, but accountability cannot. That clarity strengthens trust, ownership, and performance across the team.
How do you stay current with evolving industry trends and prepare your organization for the future?
We are living in smart times, and staying current requires conscious effort. I use social media rationally selectively engaging with credible platforms for insights rather than noise. I consistently read within my area of work to deepen my scientific and regulatory understanding.
Networking within the professional fraternity also keeps me aligned with emerging perspectives and practical experiences. Above all, I value mentorship. Having mentors allows me to test my thoughts, gain wisdom from experience, and remain grounded while adapting to change.
Drawing from your long career, what guidance would you offer to emerging leaders in this field?
My first advice is to derive a clear purpose. When your work is anchored in purpose, direction becomes clearer and resilience stronger. Be sincere and stable in whatever responsibility you undertake. Depth comes from consistency, not constant movement.
Commit yourself to continuous learning - read, upgrade your knowledge, and be willing to learn, unlearn, and relearn. The industry evolves, and so must we.
Above all, do your work well. I am deeply inspired by the words of Martin Luther King Jr., who said that what ever your calling, you should perform it with excellence. Excellence in execution, no matter the role, is what ultimately defines true leadership.
Zoher T. Sihorwala, Head – Global Regulatory Affairs, Wockhardt
Zoher T. Sihorwala is Head – Global Regulatory Affairs at Wockhardt, with over 25 years in regulatory affairs. An advocate of affordable, quality medicines, he has led global filings, contributed to regulatory science, and continues Ph.D. research on AI in pharmaceuticals.