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Dr. Hitarth Changani, a Regulatory Affairs Consultant at Parexel with over 13 years of experience in biologics development, regulatory strategy, and global post-marketing submissions.
Hitarth’s day revolves around reviewing change assessments, developing regulatory strategies, and preparing and reviewing variations and supporting documentation — working across regulated and international markets for large molecules, all while collaborating closely with affiliates and cross-functional partners to ensure timely, compliant submissions across global markets.
What keeps him going? A belief that staying hungry for knowledge and being the best colleague you can be is what makes the real difference in the work, and in the impact it has on patients.
Why Parexel
Hitarth joined Parexel in November 2023 and the decision, he says, was straightforward. “Parexel’s strong reputation in regulatory and clinical research, combined with its work policy and culture, made it the clear choice. During my interactions, it was evident that Parexel values collaboration, continuous learning, and long-term career growth rather than just delivering projects. That alignment with my own values ultimately made Parexel the clear choice.”
The work-life balance has been another marker. “I am experiencing incredible work-life balance which rightly stamps the earlier feedback I received from my friends who were working here.”
What does a regulatory affairs consultant actually do?
As a Regulatory Affairs Consultant, Hitarth provides end-to-end regulatory support to global clients, covering everything from variation filing and health authority query responses to change assessments and lifecycle compliance for biologics and biopharmaceutical products.
On what a typical day looks like: “My day usually begins with reviewing ongoing change assessments to understand the impact of proposed modifications on global submissions. I then work on developing or refining regulatory strategies that ensure compliance while meeting project timelines. A significant part of my day is dedicated to preparing and reviewing variations and supporting documentation to ensure accuracy, clarity, and alignment with regional requirements.”
The pace is constant, and so is the collaboration. “I also collaborate closely with affiliates and cross-functional partners to gather inputs, resolve queries, and coordinate the submission process.”
People, Culture and Growth at Parexel
One of the most significant things Hitarth has taken from his time at Parexel is something he hadn’t experienced quite like this before. “The most significant thing I’ve learned is collaboration across expertise and geographies. At Parexel, I’ve had opportunities to work with different colleagues from different countries and locations, which I never had. My colleagues consistently demonstrate how open communication, shared accountability, and respect for diverse perspectives can elevate both the quality of work and the overall impact on patients.”
When asked about how his role has shifted since joining, Hitarth is clear about the direction. “My role has evolved from focusing primarily on execution to taking on greater ownership and strategic thinking. I’m now more involved in anticipating regulatory challenges rather than just responding to them.”
“Parexel has supported my growth through exposure to diverse projects, access to knowledgeable mentors, and a culture that encourages skill development. There’s a genuine investment in helping employees build both technical depth and long-term career direction.”
Navigating Challenges
No role in regulatory affairs is without its complexities. On a challenge that stood out: “I faced a challenge aligning differing regulatory interpretations across stakeholders. By openly discussing concerns, leveraging team expertise, and maintaining a solution-oriented mindset, we reached a consensus that balanced compliance with project timelines. The support and trust within the team made all the difference.”
Advice to someone starting out
“Stay hungry in terms of knowledge and be the best colleague by helping others. Regulatory work evolves constantly, and the most impactful professionals are those who learn continuously and seek clarity rather than making assumptions.”
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