Smita Maliekal

Director of Regulatory Affairs

Professional Overview
Smita Maliekal is a seasoned regulatory affairs professional with over 15 years of experience in the pharmaceutical and biotechnology industries. As the Director of Regulatory Affairs at Immunovant, she is responsible for leading the company's regulatory strategy, ensuring compliance with global regulations, and driving the successful progression of the organization's drug development pipeline.

Experience Summary

Current Role
In her current role as the Director of Regulatory Affairs at Immunovant, Smita is responsible for developing and implementing regulatory strategies to support the company's drug development programs. She oversees all aspects of regulatory affairs, including managing regulatory submissions, liaising with global health authorities, and ensuring compliance with applicable regulations. Smita's expertise and strategic guidance have been instrumental in advancing Immunovant's clinical trials and driving the company's regulatory success.

Career Progression
Prior to joining Immunovant, Smita held various regulatory affairs roles at leading pharmaceutical and biotechnology companies, including Amicus Therapeutics and Daiichi Sankyo, Inc. She has a proven track record of successfully navigating complex regulatory landscapes, managing global regulatory operations, and implementing effective business process improvements. Smita's career progression demonstrates her ability to take on increasingly challenging responsibilities and drive meaningful impact within the organizations she has served.

Academic Background
Smita holds a Bachelor's degree in Commerce from the University of Mumbai. She is committed to ongoing professional development and has participated in various regulatory affairs training programs and industry conferences to stay abreast of the latest regulatory trends and best practices.

Areas of Expertise
Smita's areas of expertise include regulatory strategy and planning, regulatory submissions and registrations, global regulatory operations, business process optimization, and stakeholder management. She is adept at interpreting and applying complex regulatory requirements, and she has a deep understanding of the pharmaceutical and biotechnology industries.

Professional Impact
Throughout her career, Smita has been recognized for her ability to drive successful regulatory outcomes. At Amicus Therapeutics, she led the implementation of a global regulatory information management (RIM) system, which resulted in improved data integrity, increased operational efficiency, and enhanced cross-functional collaboration. At Daiichi Sankyo, Inc., Smita's contributions as a Senior Business Analyst and Regulatory Affairs Analyst were instrumental in supporting the company's regulatory activities and ensuring product compliance.

Conclusion
Smita Maliekal is a highly accomplished regulatory affairs professional with a proven track record of success in the pharmaceutical and biotechnology industries. In her current role as the Director of Regulatory Affairs at Immunovant, she continues to leverage her extensive expertise to support the company's drug development initiatives and drive regulatory excellence. Smita's strategic vision, technical proficiency, and collaborative leadership style make her a valuable asset to the organizations she serves.