Regulatory Process Lead Japan & Digital

/Hybrid work model

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Please make English and Japanese resume combined in one document to submit

If you have any questions please contact recruiting team

Primary Purpose / Regulatory Responsibilities:
The Regulatory process management Lead is responsible with a focus on development high quality submission planning and delivery as well as strong process and technical expertise.

The role managing/support all aspects of the end-to-end Submission process for Japan such as planning document management publishing and dispatch. Strong communication leadership technical and project management skills are required.

This position is also responsible for contributing to the development and implementation of the electronic systems and processes owned by Regulatory Affairs such as Source submission (Veeva).

This includes implementation within GRA GRA delegates and with GRA stakeholders that use the systems and processes (e.g. Affiliates Clinical Non-Clinical Safety Pharmacovigilance Technical Operations Partners).

This position is also responsible for ensuring the consistent use of submission standards processes and technologies. This role is responsible for ensuring dissemination of information related to new Regulatory submission requirements for their region and system implementations or upgrades supporting Regulatory submissions.

MAJOR RESPONSIBILITIES
Serve as Source Submission (Veeva Valt regulatory document tool) Expert within Regulatory Affairs Japan and for interface teams
Cooperate across Japan Submission Team interfaces and relevant units to develop effective working process with JST team
Act as a primary contact for all direct/indirect line reports in the context of regulatory submission tool such as Source submission Source quality AI translation system and other digital tools related to GRA.
Implement process/procedural document changes based on process improvement outcomes
Drive discussions to update existing process/procedural document based on e.g. ICH updates business needs/feedback
Assist Business Process Lead on process improvement activities if needed.
Design implement and maintain process landscapes in collaboration with functional subject matter experts
Serve as Source Quality Expert within RA Japan
Liaise between Application Owner of Source Quality ECMS if needed
stakeholders to continuously contribute to the improvement of the systems
Serve as technical point of contact for RA Japan
Liaison between UCB Japan and Vender Partners (e.g. CMIC Fujifilm trinity etc.)
Maintain dedicated process landscapes and procedural document overview

Education Level

Bachelors Degree
Masters Degree

Experience

10 years of specific experience in the pharmaceutical industry or related industries with specific experience related to the management of product licenses including
Minimum of 3 years in Regulatory Operations or Labeling development regulatory similar function including participation in implementation of new technologies as an subject matter expert
Advanced data manipulations skills using tools such as Excel and Business Objects
Leadership and Stakeholder management skills
Project management skills and experience in leading multifunctional teams
Knowledge of computer system validation requirements

Specific skills/competences
Evaluation Skill: Suggests improvements to existing processes and solutions.
Innovative:demonstrates ability to look beyond current solutions and practices and find new value add ways of working

High customer and service orientation
Passion for continuous improvement and analytical diligent in executing processes and compliance standards
Attention to detail and process orientated for example Manage Computer System Validation deliverables across all Regulated systems maintain record and project manage computer system and business projects
Strong computer skills and technical savvy e.g. MS-Office VEEVA & social media
Good communication incl. listening and presenting skills Promotional skills finds ways to advance new ideas from concept to adoption
Strong team player open and transparent with others in sharing knowledge to achieve maximum efficiency and customer satisfaction
Writing and editing abilities
Good English language skills; translation of certain content is a requirement (compliance) locally proficient in other languages a plus.
Good understanding of process improvement methodologies
Strong organizational and planning skills with ability to work under pressure
Must be able to handle confidential matters and information
Ability to interact with all levels in the organization
Positive attitude to a changing environment
Problem solving
Can manage uncertainty
Ability to support change
Ability to adapt working in a multicultural environment

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