I-Mab Biopharma is a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics to treat diseases with significant unmet medical needs, particularly cancers and autoimmune disorders. Our mission is to bring transformational medicines to patients through innovation.

This role will report directly to Associate Director, Regulatory Affairs.

Role Responsibilities:

• Draft and manage a variety of regulatory documents and submissions in eCTD via ESG to FDA, which include but not limited to, Investigational New Drug applications (INDs), Annual Reports/DSUR to INDs, Investigator’s Brochures (IBs), information amendments (nonclinical, clinical, and CMC), and any other regulatory dossiers;
• Review regulatory documents for their compliance with pertinent guidance and technical preparedness, including nonclinical CMC reports, general investigational plan, and IB, etc;
• Assist to manage timelines for the drafting, review, revision, and submission of regulatory dossiers; •
• Track on-going regulatory activities and plan for up-coming ones with the key contributors from cross-functional team to ensure timely delivery of regulatory items;
• Support the development of the Standard Operating Procedures (SOPs) of Regulatory Affairs;
• Support due diligence on regulatory intelligences, landscapes, and strategies as assigned.

• Minimum two-year working experiences in regulatory submission is a must 
• Hands-on experiences on eCTD publishing tools and software, xml file editing. 
• Strong skills in MS Word, Excel, Outlook, SharePoint, and Adobe Acrobat DC is highly desired
• Minimum BS degree in life science (e.g. Biology, Chemistry, Pharmacy or related fields)

All your information will be kept confidential according to EEO guidelines.