Christina Zhang

Christina Zhang

RO Specialist @ Willingjet Life Science Limited

About

Industry Experience oKnowledge of Drug Development/Lifecycle oKnowledge of US/EU/EMAP Regulatory Guidance oExperience of US IND Submissions (Briefing Documentation, Pre-IND Correspondence, General Correspondence, Information Amendments, Response to FDA request, Protocol Amendment, DSUR, Safety Reports…) oExperience of US NDA/BLA Submissions (Amendment to Pending Application, General/Product Correspondence, Labelling Supplement, Annual Report, PSUR…) .Experience of EMAP Submissions (PREP, Renewals, RTQ, Variation, Tender …) oExperience of EU Submissions (CTA, Scientific Advice, Briefing Document, MAA, PIP, Variation, Renewals, RTQ…)

Country

China

City

Beijing

Industry

Translation & Localization

Skill

-

Experience

Willingjet Life Science Limited

RO Specialist

Willingjet Life Science Limited

LinkedIn
2020-12 - Present · 5 yrs 10 mos

Boasting four years of hands-on experience in electronic submissions for registration documents, I am well-acquainted with the eCTD regulatory requirements stipulated by various governmental bodies. I am adept at the formatting, publishing, and validation processes required for registration documents. My role involves proactive communication with clients to address any pertinent issues, guaranteeing that all documentation tasks are executed with high quality and delivered punctually. Additionally, I am responsible for the meticulous settlement of expenses and the procurement of necessary materials. My proficiency extends to a range of software tools critical to this role, including docuBridge, Adobe Acrobat, and Microsoft Office, ensuring a seamless and efficient workflow.

Beijing Sulida Digital Printing Co.

Typesetting and Printing Specialist

Beijing Sulida Digital Printing Co.

2015-8 - 2020-11 · 5 yrs 4 mos

I meticulously process documents in alignment with customer specifications for printing, conducting thorough checks to identify any errors within the document and implementing prompt corrections. Printing is conducted within a specialized environment to ensure precision, and binding is executed in accordance with customer stipulations. This guarantees that the final printed materials, such as books and posters, are in full compliance with our clients’ exacting requirements.

Christina Zhang's Contact Information

Email

******@***.com

Phone

(**) *** ****

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