Manager, Regulatory Technology – Reg Ops

BeiGene

Department:Regulatory Affairs

Manager, Regulatory Technology – Reg Ops

Director/Sr. Director, Regulatory Affairs

The Manager, Regulatory Technology, Regulatory Affairs Operations is responsible for providing technical and system support to the growing Regulatory Operations team in BeiGene.  This person will help to establish the Regulatory Technology Function.  This position provides global support to the Regulatory Affairs and Regulatory Operations organization with an immediate focus working on project for US and Pacific, and other regional regulatory filings.  This position will collaborate closely with the Information Technology team to contribute to the overall client’s technology strategy portfolio and ensure system and processes are implemented in compliance with ISO, FDA, Sarbanes-Oxley and other regulatory requirements.

Essential Duties & Responsibilities (Primary):

  • Provides Business SME support for Regulatory Affairs in the use of systems, and development and maintenance of supporting information related to the use of Regulatory technology.
  • Establishes, updates and implements Regulatory-required formats, templates, policies, standards, and procedures for regulatory submissions.
  • Provides Business SME support for tools that manage R&D Submissions and Registrations.
  • In partnership with IT, ensures that Regulatory technology requirements are incorporated and supported by both new systems and upgraded to existing systems.
  • Provides recommendations in formulating new technology and guidance.
  • Provides recommendations on the approach for the application of expert knowledge of global regulatory requirements for systems or policies with all contributing functions that ensure submission compliance.
  • Provides Business User support and recommendations on regulatory specifications for submissions, and the ability of publishing tools and systems to support them.
  • Maintains up-to-date knowledge of global standards and procedures for regulatory submissions, including eCTD, IDMP; Publishing standards and analyzes new and revised guidance, advises regulatory management of new requirements, and recommends course of action.
  • Evaluate new tools and technologies and provide direction and support to the team on how to build these technologies into a Regulatory system portfolio.
  • Support and expand existing tools and platforms.
  • Develop and provide training on Regulatory technologies
  • Provide expertise, guidance, and leadership in Regulatory Information Management (RIM), and submission production and validation tools and strategies, to assist members of Regulatory Affairs in submission preparation and delivery.
  • Work across geographic regions to ensure support and functional needs are met.
  • Represent the needs of Regulatory Affairs system objectives in cross-functional teams.

Core Competencies, Knowledge and Skill Requirements:

  • Working knowledge of business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook.
  • Must have the ability to understand and reduce to practice Global Regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines. Experience with those would be a huge plus.
  • Knowledge of database analysis, design, and maintenance
  • Knowledge and/or experience with the Software development Lifecyle [SDLC] and IEEE standards as they pertain to the SDLC
  • Knowledge and/or experience with computer validation quality assurance for the Pharma/Biotech industry
  • Understanding of TCP /IP networking environments
  • Functional knowledge of document management, formatting and publishing software systems
  • Understanding of the drug development process
  • Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism

Communication & Interpersonal Skills:

  • Excellent interpersonal, communication, analytical and organizational skills.
  • Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.
  • Team player capable of managing multiple projects and complex timelines in a team environment
  • Ability to problem solve and trouble shoot under pressure
  • Works independently under general supervision.
  • Ability to prioritize and handle multiple projects simultaneously.

Requirements

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

preferred.

Experience:

  • 6+ years of R&D and pharmaceutical technical support and information management experience or
  • 9+ years of technical support and information management experience or
  • 11+ years of technical support and information experience without a Bachelor’s degree or
  • 3+ years of experience in electronic document management {or 5+ years without a Bachelor 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 preferred.

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

Apply using webmail: Gmail / AOL / Yahoo / Outlook