Job Description

Job Responsibilities:

• Assist Regulatory Affairs personnel in the preparation and submission of INDs/BLAs/NDAs and life cycle management.
• Electronically format and publish electronic documents; builds Regulatory submission deliverables. Ensures quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures.
• Provides guidance on good documentation and submission practices to project teams.
• Provides input on submission timelines and eCTD content plans.
• Reviews documents to ensure compliance with electronic requirements
• Support archiving (categorizing and classifying information) of Regulatory records pertaining to multiple Regulatory Applications (e.g., IND, BLA, MAA, Annual Reports, AEs), maintaining Regulatory Application indexes, tracking of regulatory submission documents, and special projects as needed.
• Identifies and communicates regulatory system enhancement needs or technical issues
• Assist with maintaining Document Authoring Template Library and Template development
• Contribute to miscellaneous regulatory operational activities and special projects as assigned.

Job requirements:

• BA/BS degree in Life Sciences or related field
• 1 – 3 years of experience in Regulatory Operations, Regulatory Affairs, or related publishing/technical documentation role
• Basic knowledge of regulatory practices, electronic submission guidelines and requirements.
• Familiarity with electronic Common Technical Document submission requirements during development, registration and commercialization
• Experience working in a cross-functional environment and supporting submission deliverables.
• Strong attention to detail, good organization, and collaboration skills.
• Ability to manage multiple tasks simultaneously and meet deadlines.
• Familiarity with applicable FDA, EMA and ICH guidelines related to regulatory submissions, clinical trials and marketing applications.
• Familiarity with eCTD publishing systems, EDMS technology (Veeva Vault preferred), and document authoring tools and templates.
• Proficiency in Microsoft Office Suite, Adobe, Excel.
• Understanding of regulatory submission content and format requirements.
• Understanding of applicable FDA and ICH guidelines related to regulatory submissions.
• Clear understanding of regulatory submission content and format requirements.
• Experienced in lifecycle management eCTD submissions including but not limited to, IND Safety, IND Investigator submissions and post marketing LCM.
• Ability to work both independently and collaboratively in a fast-paced environment.
• Detail-oriented with strong organizational and time-management skills.
• Strong written and verbal communication skills.
• Mandarin language skills a plus; East Coast (U.S.) location strongly preferred for time zone alignment.

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