Scientist, China Nonclinical Submission

Auris Health

Auris Health

Shanghai, China
Posted on Monday, July 31, 2023
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Job Description:
Preclinical Sciences and Translational Safety (PSTS) China within Janssen Research & Development is looking for a nonclinical submission scientist. The scope of this position includes, but is not limited to, serving as China compound team (CCT) member to represent PSTS China, working with project nonclinical leaders to contribute to health authority (HA) consultation briefing book, generate nonclinical questions and company positions, and address nonclinical questions that CCT and HA may inquire; identifying the required PSTS relevant documents supporting China CTA/NDA/BLA submissions, coordinating with global PSTS functions in preparing the documents for Janssen China R&D (JCRD) submission dossiers, and facilitating on time delivery of nonclinical documents with excellent and consistent quality and in compliance with internal and external guidelines.  The position will work closely with JCRD Regulatory Affairs, Medical Writing and global PSTS Submission and PSTS Project leaders, and Operation teams for document preparation, issue resolving, and submission processes.
Primary Responsibilities:
•    Provide PSTS nonclinical support (pharmacology, toxicology, DMPK, etc.) for regulatory submission activities for JCRD projects.
•    Serve as a CCT member to represent PSTS China to address CCT or HA nonclinical inquiry.
•    Identify, collect, track, and prepare (or facilitate preparing) the required nonclinical relevant documents to support China CDA/NDA/BLA submissions.
•    Work with global PSTS Submission and Operation teams, develop the document preparation workflow. 
•    Coordinate PSTS contributions to JCRD submission documents such as GLP statements, CRO GLP certificate/inspection report, IB, IND, CTA, NDA, BLA, DSUR, briefing books, toxicology/DMPK reports, etc.
•    Provide functional validation to Chinese translation of all PSTS nonclinical (pharmacology/toxicology/DMPK/…) relevant submission documents.
•    Enable high quality and on time delivery of PSTS documents to support JCRD submission.
•    Provide response to JCRD compound team and China HA inquiries on PSTS documents.
•    Ensures regulatory compliance and adherence to internal business standards.
•    Keep up with the dynamic regulatory environment; stay familiar with Chinese and important global (CDE, FDA, EMA, ICH) guidelines, and when opportunity arise, contribute to new guideline revision.


•    A PhD/Master’s degree or equivalent degree in toxicology, pharmacology, DMPK or other relevant bio-medical science discipline. 
•    Proven experiences in regulatory toxicology or DMPK supporting CTA/NDA. In-depth understanding of non-clinical sciences in new drug development with > 5 years working experience in pharma/biotech/CROs
•    Knowledge of China and important global (CDE, FDA, EMA, ICH) guidelines on nonclinical safety evaluation
•    Highly self-motivated and innovative mindset 
•    Be open and collaborative with internal and external partners (for example global PSTS colleagues, regulatory affairs, health authorities, and CROs,)
•    Good organizational and multi-tasking capabilities to ensure quality and timely delivery 
•    Excellent communication skills (English and Chinese), strong interpersonal skills and excellent team player