Smita Maliekal, Director of Regulatory Affairs
Professional Overview
Smita Maliekal is an accomplished regulatory affairs professional with over 15 years of experience in the pharmaceutical and biotechnology industries. As the Director of Regulatory Affairs at Immunovant, she leverages her deep expertise in regulatory operations, business process optimization, and global regulatory compliance to drive strategic initiatives and ensure the timely delivery of regulatory submissions.
Experience Summary
Current Role
As the Director of Regulatory Affairs at Immunovant, Smita leads a team of regulatory affairs specialists responsible for managing global regulatory strategies, submissions, and lifecycle management for the company's pipeline of innovative therapies. In this role, she has spearheaded the implementation of robust regulatory operations, optimizing business processes and driving cross-functional collaboration to enhance the efficiency and quality of regulatory deliverables.
Career Progression
Smita's career progression showcases her versatility and commitment to continuous learning. Prior to her current role, she served as the Associate Director of Regulatory Affairs Operations at Immunovant, where she played a pivotal role in streamlining regulatory business processes and driving digital transformation initiatives. Additionally, she has held various regulatory affairs and business analyst positions at leading pharmaceutical companies, including Amicus Therapeutics, Daiichi Sankyo, and Bristol-Myers Squibb, demonstrating her ability to navigate complex regulatory landscapes and contribute to the success of her organizations.
Academic Background
Smita holds a Bachelor's degree in Computer Science and Engineering, showcasing her strong technical foundation and aptitude for leveraging technology to solve complex business challenges.
Areas of Expertise
- Regulatory affairs operations and lifecycle management
- Global regulatory strategy and submission planning
- Digital transformation and business process optimization
- Cross-functional collaboration and stakeholder management
- Regulatory intelligence and risk mitigation
Professional Impact
Throughout her career, Smita has consistently delivered measurable results, contributing to the successful regulatory approval and commercialization of several pharmaceutical products. Her ability to streamline regulatory processes, enhance submission quality, and foster collaborative partnerships has made her a valuable asset to the organizations she has served.
Conclusion
Smita Maliekal's extensive experience, combined with her strategic mindset and strong technical capabilities, positions her as a highly skilled regulatory affairs professional. In her current role at Immunovant, she continues to drive innovation and ensure the successful navigation of global regulatory landscapes, contributing to the advancement of the company's pipeline and ultimately benefiting patients worldwide.
