Shile Wang
@shilewang
Regulatory affairs specialist advancing vaccine submissions and clinical dossiers for biotech.
ChinaWhat I'm looking for
I’m a Regulatory Affairs Specialist focused on getting vaccine programs safely from IND strategy to submission-ready dossiers. With a Master of Clinical Pharmacology from the University of Glasgow and Applied Statistics for Clinical research coursework, I combine clinical development rigor with practical regulatory execution.
At Xiamen Innovax Biotech, I led pre-IND and IND submissions for RSV vaccine candidates, coordinated internal R&D and outsourced CROs for CTD Modules 1–4 authoring, and completed dossier consistency audits plus e-submission validation—ultimately securing RSV vaccine IND approval. I also manage regulatory intelligence for multiple markets (CTA/MAA and post-marketing changes) and handle post-marketing variation filings for 2-valent HPV and Hepatitis E vaccines, including shelf-life extensions and supplier onboarding.
Experience
Work history, roles, and key accomplishments
Regulatory Affairs Specialist
Xiamen Innovax Biotech Co., Ltd
Jan 2025 - Present (1 year 5 months)
Led pre-IND and IND submissions for RSV vaccine candidates, coordinating CTD Modules 1–4 authoring with internal R&D and outsourced CROs and completing dossier consistency audits plus e-submission validation; secured RSV vaccine IND approval. Managed regulatory intelligence for multiple target markets and handled post-marketing variation filings for 2-valent HPV and Hepatitis E vaccines, including
Global License-in BD Specialist
Xiamen Innovax Biotech Co., Ltd
Dec 2023 - Jan 2025 (1 year 1 month)
Coordinated global partner communications and cross-functional teams for clinical trial kick-off and progress reviews (including a 9-valent HPV study), finalizing IMPD, Investigator’s Brochure, and clinical trial labeling for submissions. Performed desktop due diligence, screened 3 in-licensing vaccine candidates, and managed outsourced CRO/CDMO timelines to support RSV (adjuvanted) and PCV20 clin
Education
Degrees, certifications, and relevant coursework
University of Glasgow
Master of Clinical Pharmacology (MedSci), Clinical Pharmacology
2022 - 2023
Activities and societies: Main courses: Applied Statistics for Clinical research, Principles of Pharmacology, Drug Disposition, and GCP (etc.).
Completed a Master of Clinical Pharmacology (MedSci) program focused on clinical research and pharmacology. Coursework included applied statistics for clinical research, drug disposition, and GCP.
Huaqiao University
Bachelor of Pharmaceutical Engineering, Pharmaceutical Engineering
2018 - 2022
Activities and societies: Main courses: Pharmaceutical Manufacturing Safety, Process Engineering, Biochemistry, Immunology, Pharmacology (etc.).
Earned a Bachelor of Pharmaceutical Engineering covering pharmaceutical manufacturing, process engineering, and related life-science foundations. Coursework included biochemistry, immunology, and pharmacology.
Availability
Location
ChinaAuthorized to work in
Job categories
Skills
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