BACKGROUND
FOCUS AREAS
Senior Regulatory Project Manager with extensive experience in US regulatory affairs, specializing in eCTD submissions and FDA interactions.
Regulatory compliance
Facilitating FDA interactions
Managing regulatory projects efficiently to achieve timely approvals and successful outcomes
As a Senior Regulatory Project Manager at Eliquent, Cynthia has been an integral part of the team since joining in 2021. With specialized expertise in client relationships, project management, US regulatory strategies, IND eCTD submissions, she has successfully managed numerous projects. Her extensive experience includes handling PINDs, INDs, EOP1s, EOP2s, NDAs, BLAs, FTs, and ODD submissions. Additionally, she has facilitated numerous interactions and meetings with the FDA, ensuring compliance and smooth regulatory processes. Her commitment to excellence and strategic approach continue to drive successful outcomes for our clients.
With a strong background in regulatory affairs, Cynthia brings a wealth of knowledge and a keen eye for detail to every project she undertakes. Her proficiency in navigating the complexities of regulatory submissions and her ability to streamline the process have been instrumental in achieving timely approvals. She is adept at eCTD publishing quality control, ensuring that all documentation is meticulously prepared and submitted.
Her project management skills are complemented by her strategic insight into US regulatory landscapes. She is known for her ability to develop and implement effective regulatory strategies that align with both client goals and regulatory expectations. Her experience in managing interactions with the FDA, including face-to-face meetings and written correspondence, has been pivotal in fostering positive relationships and facilitating smooth communication between clients and regulatory bodies. Her dedication to staying current with regulatory trends and changes ensures that her clients are always well-prepared and informed.
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EDUCATION:
Johns Hopkins Bloomberg School of Public Health, 2019 – 2021, Master of Science in Public Health
Sun YatSen University (SYSU), 2014 – 2019, Bachelor of Science in Public Health -
PROFESSIONAL EXPERIENCE:
Senior Regulatory Project Manager at Eliquent, 2023–Present
Regulatory Project Manager at DataRevive, 2021-2023AREAS OF EXPERTISE:
eCTD Publishing and Submissions
US Regulatory Strategy
FDA Interactions
Project Management and Client Relationship
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