In a recent conversation, Deepaben Bhavsar, a seasoned regulatory affairs professional based in Iselin, New Jersey, shared her strategic approach to leading global regulatory submissions and fostering innovation in the pharmaceutical landscape.

With a Master’s in Project Management from Northeastern University and a Bachelor’s in Pharmacy from Dharamsinh Desai University, Deepaben seamlessly blends scientific knowledge with regulatory acumen. “My passion for regulatory affairs was born from a desire to ensure timely patient access to safe and effective medications,” she says. “It’s a field where science, policy, and patient impact intersect meaningfully.”

Over the years, she has led numerous global regulatory submissions with a structured, project-driven methodology. “I approach each submission like a project manager—breaking down complex timelines, deliverables, and team responsibilities,” Deepaben explains. Leveraging tools such as Asana, she builds clear roadmaps, tracks progress, and coordinates seamlessly across global teams.

In a field defined by constant change, adapting to evolving regulations is crucial. Deepaben tackles this challenge by staying informed through regulatory intelligence platforms, industry conferences, and peer forums. “I routinely conduct gap analyses and formulate strategies that anticipate potential agency concerns,” she notes. “It’s all about being proactive, not reactive.”

Collaboration lies at the heart of her work. Deepaben regularly interfaces with cross-functional partners across clinical, non-clinical, CMC, and project management functions. “Translating complex regulatory requirements into actionable plans for each stakeholder is essential,” she says. “It helps ensure alignment and strengthens the quality of submissions.”

Measuring the success of a submission extends beyond approval, Deepaben emphasizes. “We look at KPIs like submission timelines, the volume of agency questions, and how our approval timeline compares to industry norms. These metrics reflect both efficiency and quality.”

Innovation also plays a vital role in Deepaben’s leadership philosophy. She encourages her teams to seek process improvements and leverage tools that enhance compliance and efficiency. “I’ve developed templates and standardized workflows that reduce preparation time and ensure consistency,” she adds. “Efficiency doesn’t mean cutting corners—it means streamlining intelligently.”

When unexpected feedback arises from agencies like the FDA, Deepaben applies a solutions-focused mindset. “I lead discussions grounded in data and regulatory precedent, working collaboratively to resolve issues and strengthen our strategy,” she explains.

Looking ahead, she sees promise in AI-powered document review tools and global regulatory harmonization. “As electronic submission technologies advance and real-world evidence becomes more integral, we’ll be able to streamline timelines and enhance global access to innovative therapies,” she reflects.

Deepaben continues to track trends in areas like rare disease therapies and AI in clinical trials, where she believes regulatory agility will be key. “Our field is evolving rapidly, and it’s exciting to be part of shaping how regulations adapt to scientific innovation.”