Rishi Chopra

“Early in my career, I spoke to patients who told me, “When you’re living with a serious, life-limiting condition, the benefit of a medicine can far outweigh the potential side effects. I don’t focus on the risks … because the benefit is life changing.”

That perspective really stays with you. And it’s a big part of what my team and I are here to do. Yes, we work to ensure patients around the world can access life-changing therapies (no small feat given the complexity of regulatory frameworks across different countries). But just as importantly, we make sure the right structures are in place to continuously monitor those medicines in real-world use, because our job is to focus on the benefits and the risks for the patient.

That important balance between benefit and risk is always grounded in sound data, clearly understood, and centred on patient safety. It’s about getting safe and effective medicines to patients as quickly as possible and then sustaining that access – without ever compromising on safety, even after approval. That’s how we create impact that truly lasts.

During my studies as a biochemist, I saw situations where the safety profile of a therapy wasn’t assessed adequately and so it led to side effects impacting patients, and therapies being removed from market. But statistically, these side effects were unlikely to show up during clinical trials, so it emphasised the importance of good pharmacovigilance (GvP). And that’s what led me to this discipline.

Patient safety is the responsibility of everyone in the organisation, and it starts right at the very beginning, during product development. Pharmacovigilance is about making sure medicines remain safe and effective for the people who rely on them. Even after a medicine is out in the real world, our teams globally are constantly monitoring how it performs – collecting information, identifying patterns, and making sure we understand and manage any potential safety signals. We talk to healthcare professionals and patients daily about safety experiences or the impact a medicine has had on patients’ lives. We also hear from people who are trying to get access to a medicine or therapy.

Regulators, healthcare professionals, and patients trust us to demonstrate at any given time that our medicines meet the highest safety and efficacy standards - ensuring ongoing access for the patients who depend on them. Delivering on that trust requires Pharmacovigilance and Regulatory Affairs to work in lockstep, integrating safety evidence with regulatory pathways to sustain access globally. And that’s where the other part of my role comes into play.

At its core, Regulatory Affairs is about enabling that access - whether that’s bringing a medicine into a new country or expanding its use to benefit more patients. Each market has its own regulatory framework, often highly complex, and our role is to navigate that complexity with precision and integrity.

We ensure that life-changing therapies reach patients in full compliance with local requirements, underpinned by robust science and a clear, evidence-based understanding of their safety and efficacy. That means working in close partnership with health authorities to ensure the right data and insights are in place to support both initial approvals and sustained access over time.

For example, in Korea, we recently secured orphan drug designation for one of our rare disease therapies - an important milestone that will help accelerate access for patients who have limited treatment options.

Together Pharmacovigilance and Regulatory Affairs sit at the heart of our company’s license to operate by making sure life-changing therapies not only reach patients around the world but continue to be used safely and responsibly long after they’re approved. Right now, I’m focused on shaping a globally integrated Pharmacovigilance and Regulatory Affairs network that is built for speed and rigour - using smarter processes and advanced technologies to grant access to therapies faster, while maintaining the highest standards of patient safety and regulatory excellence.

I’ve always believed that the patient is my true employer. The company is the platform that allows me to deliver on that responsibility. That’s why choosing where to work has always been incredibly important to me. What sets CSL apart is the shared commitment to that purpose. A real community of closely connected colleagues that have a genuine focus on delivering therapies that make a meaningful difference to patients’ lives. Throughout my career, expanding or sustaining access to medicines has been my anchor. Because ultimately, there is always a patient waiting. And they are the ones that matter the most.”