Job Description

#Exciting opportunity to join in global innovative drug development team, work with seasoned RA leader for US/EU/Japan registration for Phase II/III IND/NDA approvals! #

Responsibilities:

· This role supports multiple global regulatory projects, ensuring compliance with all relevant regulatory requirements and guidelines

· Assist and help prepare and submit regulatory filings (e.g., IND, CTA/IMPD, annual reports/progress reports, briefing documents, etc.)

· Follow up on global regulatory initiatives in preparation and submission of global marketing authorization applications

· Work with global regulatory lead to create and maintain submission project plans, content plans, and responsibility matrices and timelines to ensure consistency and completeness to standards for all regulatory submission

· Manage regulatory infrastructure (document management system)

Required Education/Qualifications/Skills:

· Bachelor's degree (scientific or clinical background desirable) required; advanced degree preferred

· Minimum 5 years of the pharmaceutical or biotechnology industry required at least 3 years’ experience in Innovative drug global registration

· Experience with creating and managing INDs/CTAs, Annual reports/DSURs, and IND/CTA information amendment submissions

· Experience with preparation and review of electronic format (eCTD) submissions

· Direct interaction with FDA is preferred Experience in submission writing and review experience are essential

· Excellent organizational, planning, and follow-up skills. Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter

· Strong interpersonal skills to collaborate effectively across multiple functional areas

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