Associate, Regulatory Technology – Regulatory Operations

BeiGene

Department:Regulatory Affairs

Reports to (Title):Manager, Regulatory Technology, Regulatory Operations

The Associate, Regulatory Technology, Regulatory Affairs Operations is responsible for providing submission publishing and technical support of the Regulatory systems for BeiGene.  This position provides global support to the Regulatory Affairs and Regulatory Operations organizations with an immediate focus of supporting technical projects and regional regulatory filings.  This position will collaborate closely with the submission project managers for submissions and the Information Technology team for the Regulatory technology platforms to ensure system and processes are followed in compliance with ISO, FDA, Sarbanes-Oxley and other regulatory requirements.

Essential Duties & Responsibilities (Primary):

  • Submission Publishing:
    • Format MS Word and Adobe Acrobat files to a state of submission-readiness
    • Tracks and compiles submission component documents from paper and/or electronic sources; edits, formats, assembles, and publishes submission documents in accordance with established timelines.
    • Ensures completion of high-quality submissions in electronic (eCTD) and paper format for compliance with all applicable regulations, guidance’s, and Regulatory Operations document specifications.
    • Assists submission authors and regulatory liaisons in the planning and preparation of regulatory submissions; when appropriate, composes regulatory forms, correspondence, and text.
    • Assists in the development of and implements documentation standards, templates, and procedures related to the formatting, publishing, and archiving of both electronic (eCTD) and paper submissions.
  • Technology Support
    • Provides Business SME support for Regulatory systems and tools that manage R&D Submissions and Registrations
    • Maintains Regulatory-required formats and templates per policies, standards, and procedures for regulatory submissions.
    • Provide training and support on Regulatory technologies
    • Work across geographic regions to ensure support and functional needs are met.
    • Maintain up-to-date knowledge of global standards and procedures for regulatory submissions, [including eCTD, IDMP] publishing standards and analyzes new and revised guidance providing input to new requirements

Core Competencies, Knowledge and Skill Requirements:

  • Working knowledge of Microsoft Office and Adobe systems.
  • Must have good technical skills with software
  • Knowledge of document management systems, document formatting and publishing software systems a plus
  • Knowledge of computer systems, databases and experience with system maintenance and the software development lifecycle [SDLC] a plus

Communication & Interpersonal Skills:

  • Excellent written, verbal, and interpersonal communication skills.
  • Team player capable of managing multiple projects and complex timelines in a team environment
  • Excellent organizational and multi-tasking skills.
  • Ability to problem solve and trouble shoot under pressure
  • Ability to work independently under general supervision and adapt to changing priorities

Requirements

Education:  Bachelor’s degree or related experience is required. Computer science field a plus.

Experience:

  • 0-3+ years of R&D and pharmaceutical technical support and information management experience or
  • 3+ years of technical support and information management experience or
  • 4+ years of technical support and information experience without a bachelor’s degree or
  • 1+ years of experience in electronic document management (or 3+ years without a bachelor’s degree).
  • Experience in the preparation and submission of documents using regulatory/document management systems {e.g. VAULT®, Documentum®, FirstDocs®, Publishing Tools, and Validation tools) is highly desirable.

Travel, Physical DEmands and work environment (AS APPROPRIATE FOR THE POSITION)

Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)

To apply for this job email your details to us.careers@beigene.com

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