Job Number:

External Description:

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 company and Vender Partners

•    Maintain dedicated process landscapes and procedural document overview

Education Level

Bachelor's Degree
Master's 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

Job Number:

Community / Marketing Title:
Regulatory Process Lead Japan & Digital Technology

Location_formattedLocationLong:
Tokyo, Tokyo JP