メディカル・バイオ - 薬事申請

【Job Purpose & Key Responsibilities ​】
As a Japan Submission manager, you will work not only with Japan submission teams but also with Global Submission Managers closely and as needed with Global Publishers and Global Submission teams to manage complex regulatory submissions (including marketing applications, product line extensions, and submissions related to products under development) from the development stage through to approval, ensuring that applications and dossiers are prepared in a very timely manner and in compliance with Regulatory Authority regulations and guidance and with GSK SOPs and working practices.

- Lead Japan submission planning and publishing discussions within Japan and in close collaboration with Global Submission Managers, ensuring the team is aware of upcoming deliverables, aligned on roles and responsibilities, understands the interdependencies between submission activities and components, and that any issues, risks, or impact due to changes in strategy and/or timelines are assessed quickly throughout the submission process.

- Through collaboration with contributing functional lines within Japan, capture a detailed list of Japan specific dossier content, key global/local activities and timelines associated with delivery of that content, and provide inputs to Global Submission Managers for them to create and maintain a Global Submission Plan.

- Utilize in-depth knowledge of Japan regulatory submission requirements, processes, and procedures, eCTD structure, format and publishing, and associated GSK systems to ensure teams meet target submission dates by proactively focusing on critical path analysis, hand offs, scenarios, and reducing “rework” to avoid costly time delays.

- Understand and advise stakeholders, contract workers and others concerned locally and globally on Japan regulatory authority regulations and guidance associated with electronic submissions and gateway.

- Use process improvement tools and approaches to support team effectiveness and delivery.
- Author new process documentation and ensure appropriate monitoring and reporting are in place.

- Lead Japan public disclosure, serving as the main point of contact with local regulatory authorities and ensuring Commercially Confidential Information (CCI) and Personally Identifiable Information (PII) are redacted properly through collaboration with Central CCI and PII reviewers and Japan submission teams.

*Future scope of job and working location will be determined by company.

■休日：完全週休二日制, 年末年始

【Basic Qualification】
■Skill
・Degree in a biological, healthcare, or scientific discipline or Extensive experience within the drug development environment
・Good written and verbal communication skills and the ability to present information in a clear and concise manner

■Education/certification/Language
・Basic English communication skill

【Preferred Qualification】
■Skill
・Knowledge of regulatory affairs responsibilities from early development through Phase I-IV
・Project management experience in an R&D environment
・Demonstrated negotiation skills with the ability to persuade and influence others (regardless of level) in achieving team objectives.
・Ability to proactively identify and mitigate risks and potential bottlenecks and effectively interact with stakeholders to ensure transparency of submission progress and status.
・Organizational skills, attention to detail, and commitment to deliver high-quality output, even under pressures sometimes demanded by regulatory deadlines.
・Ability to work in a matrix environment and ensure delivery of objectives across cross-functional teams.

■Experience
・Regulatory experience

■職種未経験者：不可