Ankit Mehta
Director of Regulatory Affairs
Somerville, Massachusetts, United States
Professional Overview
Ankit Mehta is a seasoned regulatory affairs professional with over a decade of experience in the pharmaceutical and biotechnology industries. As the Director of Regulatory Affairs at Vor Biopharma, he plays a key role in navigating the complex regulatory landscape, ensuring the company's innovative therapies meet stringent safety and compliance standards.
Experience Summary
Current Role
As the Director of Regulatory Affairs at Vor Biopharma, Ankit is responsible for leading the company's regulatory strategy and operations. He oversees the preparation and submission of regulatory filings, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs). Ankit also collaborates closely with cross-functional teams to address regulatory requirements and ensure timely approvals for Vor's pipeline of cell and gene therapies.
Career Progression
Ankit's regulatory affairs expertise has steadily grown throughout his career. He started as an Associate Scientist in Process Development at Merck, where he gained hands-on experience in biopharmaceutical manufacturing and quality control. Ankit then transitioned into regulatory affairs, serving as a Senior Specialist in Regulatory CMC, Biologics at Merck. In this role, he honed his skills in navigating the complex regulatory landscape and driving successful submissions.
Seeking new challenges, Ankit joined Homology Medicines, Inc. as a Manager in Regulatory Affairs, where he played a pivotal role in advancing the company's gene therapy pipeline. His strong performance led to a promotion to Associate Director Regulatory Affairs, a position he held until joining Vor Biopharma in 2020.
Academic Background
Ankit holds a Bachelor of Technology in Biotechnology from the National Institute of Technology, Rourkela, India. His academic accolades include graduating with Distinction and receiving the Institute Silver Medal for his exceptional academic performance.
Areas of Expertise
- Regulatory strategy and operations
- Regulatory submission preparation and management
- Navigating global regulatory frameworks (FDA, EMA, PMDA)
- Cell and gene therapy regulatory requirements
- Biopharmaceutical manufacturing and quality control
- Cross-functional collaboration and stakeholder management
Professional Impact
At Vor Biopharma, Ankit has been instrumental in shaping the company's regulatory strategy, ensuring the smooth progression of its innovative cell and gene therapy pipeline. He has successfully guided the submission and approval of multiple INDs, enabling Vor to advance its groundbreaking therapies into clinical trials.
Ankit's deep understanding of regulatory requirements and his ability to effectively communicate with stakeholders have made him a valuable asset to the organizations he has worked with. His contributions have been recognized through promotions and increased responsibilities throughout his career, culminating in his current role as the Director of Regulatory Affairs at Vor Biopharma.
Conclusion
With his extensive experience, strong technical expertise, and proven track record of regulatory success, Ankit Mehta is well-positioned to continue driving Vor Biopharma's regulatory strategy and contributing to the advancement of transformative cell and gene therapies. His dedication to navigating the evolving regulatory landscape and his commitment to patient safety make him a valuable leader in the biopharmaceutical industry.
