Claudia Cao
Nanjing
Summary
Growing from an international sales to a RA manager in past 7 years, I practiced my English skill with foreign partners and became skillful on the RA work from both linguistic perspective and professional perspective. I learned a lot about how a drug develops from a very early status to the final marketing upon the agency’s approval, especially innovative drugs. I’m very familiar with the usual registration application types such pre-IND, IND, NDA/BLA, communication meetings, etc.
Overview
15
15
years of professional experience
Work History
RA Manager
Nanjing Novostream Pharmaceutical Technology Co., Ltd.
10.2023 - Current
- Manage the assigned RA projects and coordinate with internal and external teams to achieve multiple delivery milestones;
- Review all submission packages and ensure the overall material quality meets regulatory technical requirements by different agencies;
- Keep tracking on the review progress of drug registration applications and resolve any registration issues during the review process;
- Provide the regulatory affairs consultation, bidding support, etc.;
- Project Experience: 1 IDL Renewal, 2 Pre-NDA, 1 IND and 1 EOP2
- E-submission experience (via web transfer)
Senior RA Manager
Jiangsu TriApex Laboratories Co., Ltd
04.2023 - 09.2023
- Provide the regulatory compliance support for nonclinical projects, especially advanced therapies, such as mRNA, oligonucleotides, cell therapy, gene therapy, etc.;
- Prepare or review the nonclinical section for IND submissions;
- Project Experience: 4 IND projects including 2 AAV gene therapies and 2 modified new drugs
- E-submission experience (via CD form)
RA Manager
Novotech
04.2022 - 04.2023
- Prepare the IND submissions of import innovative drugs;
- Cooperate with clinical team on the regulatory start-up of MRCT trials and match the project timeline;
- Support the internal team and clients by providing the regulatory affairs consultation;
- Project Experience: 3 pre-IND and IND projects (phase 2/MRCT/ therapeutic vaccines);
- E-submission experience (via CD form)
Deputy RA Manager
Nanjing CR Medicon Pharmaceutical Technology Co., Ltd.
07.2018 - 04.2022
- Responsible for RA projects of new drugs and generic drugs, such as INDs, ANDAs, API filing, etc.;
- Responsible for regulatory affairs consultation, especially foreign regulatory guidelines;
- Project Experience: 6 pre-IND and IND submissions (category 1 new drugs and category 2 modified new drugs), 3 ANDA submissions, 2 API filing;
- Both paper submission and E-submission projects experience (via CD form)
International Sales Manager
Nanjing Norris Pharmaceutical Co., Ltd.
08.2015 - 05.2018
- Responsible for international sales of APIs and intermediates;
- Responsible for business development of foreign markets
International Sales
Jiangsu Oversea International Co., Ltd.
07.2010 - 05.2015
- Responsible for international sales of textile products;
- Responsible for business development of foreign markets
Education
Bachelor of Science - Pharmaceutical Engineering (Part-Time)
03-2025
Bachelor - English
06.2010
Skills
- Project management
- Team leadership
- Strategic planning
- Operational efficiency
Position
RA Manager
Department
Regulatory Affairs
Office Location
Nanjing, Jiangsu
Qualifications And Certifications
12/2009, Higher Education Foreign Language Professional Steering Committee, TEM-8
Languages
Chinese (Mandarin)
Native language
English
Proficient
C2
Timeline
RA Manager - Nanjing Novostream Pharmaceutical Technology Co., Ltd.
10.2023 - Current
Senior RA Manager - Jiangsu TriApex Laboratories Co., Ltd
04.2023 - 09.2023
RA Manager - Novotech
04.2022 - 04.2023
Deputy RA Manager - Nanjing CR Medicon Pharmaceutical Technology Co., Ltd.
07.2018 - 04.2022
International Sales Manager - Nanjing Norris Pharmaceutical Co., Ltd.
08.2015 - 05.2018
International Sales - Jiangsu Oversea International Co., Ltd.
07.2010 - 05.2015
Chinese Pharmacopeia University - Bachelor of Science, Pharmaceutical Engineering (Part-Time)
Nanjing University of Aeronautics and Astronautics - Bachelor, English
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