Gina Lee
Foster City,CA
Summary
Diligent CMC Regulatory Affairs Manager who has years of pharmaceutical industry work experience, particularly in ensuring products meet regulatory regulations. Has interests in pursuing a career in Regulatory Affairs Advertising and Promotion. Excels in fostering cross-functional collaboration and manages multiple complex biologic regulatory submissions. Equipped with excellent knowledge of the FDA and global regulations, as well as Gilead regulatory tools, policies and procedures.
Well-versed in understanding and interpreting regulatory guidelines, and committed to ensuring seamless regulatory submissions and fostering compliance.
Overview
9
9
years of professional experience
10
10
years of post-secondary education
Work History
Regulatory Affairs Manager, CMC
Gilead Sciences, Inc.
08.2021 - Current
- Provide commercial and clinical regulatory support for Trodelvy
- Work with regulatory affairs to assess any impact on labeling
- Prepare Biologic License Applications for commercial launch
- Prepare briefing packages for Type C meetings with FDA
- Engage in regulatory strategy discussions with cross functional sub-teams to provide regulatory support for commercial Trodelvy
- Maintain knowledge of scientific content, drug development and regulatory requirements such as ICH, FDA and global guidelines
- Engage in regulatory discussions with health authorities, including PMDA (Japan)
- Serve as a functional CMC representative to support over 15 major US and global commercial submission rollouts by effectively aligning the strategies and timelines for post approval submissions
- Utilize Gilead regulatory tools such as RDMS, SIMS, GRASP and Insight for Viewing to to support the lifecycle management and dispatch of various regulatory submissions
- Prepare response to information requests from health authorities
- Monitor workflow to ensure overall project efficiency and adherence to project timelines
CDER Office of Clinical Pharmacology - Extern
Food and Drug Administration
02.2021 - 04.2021
- Analyzed and assessed IND/NDA submissions for multiple indications
- Attended weekly IND/NDA meetings, clinical pharmacology briefings, scoping meetings, and advisory committee meetings
- Conducted and presented pediatric oncology research outcome on the implementation of the RACE for Children Act to the team
- Attended weekly pediatric review committee (PeRC) meetings on iPSP waivers, deferrals and written requests
Regulatory Affairs/Business Development Associate
Huons Global Co. Ltd.
02.2016 - 06.2017
- Managed regulatory submission process and registration activity for existing products in South Korea and United States
- Organized and compiled documents for 0.9% Sodium Chloride Injection for ANDA approval
- Attended and organized meeting minutes for a pre-IND meeting at the US Food and Drug Administration headquarter to discuss clinical trial strategies
- Assisted the 2018 FDA site inspection and mock inspections as a scriber
- Translated SOP, CAPA, Deviation, batch production record and other GMP documents from Korean to English and vice versa
- Attended meetings with regulatory consultants to discuss ways to expedite, secure and optimize regulatory approvals concordant with company goals
- Strategized in cross functional meetings to further develop product quality and ensure compliance from medical, regulatory and legal perspectives
- Held exhibitions at the 2017 U.S. Bio International Convention in San Diego to promote pipeline products
Education
Doctor of Pharmacy - Pharmacy
University of Southern California
Los Angeles, CA 08.2017 - 05.2021
Master of Science - Regulatory Science
University of Southern California
Los Angeles, CA 06.2018 - 05.2021
Bachelor of Science - Biology
Emory University
Atlanta, GA 08.2011 - 12.2014
Skills
A good knowledge of federal and international regulations and quality systems
Proficient in utilizing regulatory tools in PC setting
Passionate learner who is quick at adapting to changes with excellent communication and project management skills
Strong interpersonal and communication skills with strong managerial skills; ability to maintain good relationship with internal and cross-functional teams
Excellent analytical skills with good organizational and time management skills to compliantly meet goals and objectives
Timeline
Regulatory Affairs Manager, CMC
Gilead Sciences, Inc.
08.2021 - Current
CDER Office of Clinical Pharmacology - Extern
Food and Drug Administration
02.2021 - 04.2021
Master of Science - Regulatory Science
University of Southern California
06.2018 - 05.2021
Doctor of Pharmacy - Pharmacy
University of Southern California
08.2017 - 05.2021
Regulatory Affairs/Business Development Associate
Huons Global Co. Ltd.
02.2016 - 06.2017
Bachelor of Science - Biology
Emory University
08.2011 - 12.2014
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