メディカル・バイオ - 薬事申請

■Primary purpose and function of this position
・ Is responsible for developing the regulatory strategy, preparation and execution of
regulatory submissions (HA consultation documents, Clinical Trial Notification (CTN),
Marketing applications (MAs)) for innovative products with various tactics to
expedite product registrations.
・ Requires a strong understanding and knowledge of local regulatory requirements, and also
actual experience of leading regulatory activities in Japan (e.g. CTN, PMDA consultation,
J-NDA dossier preparation and filing).
・ Need a strong communication skills and built excellent trust-based relationship with HAs
(e.g. MHLW, PMDA) and with various internal stakeholders (Incl. Innovative Medicines
Regulatory Affairs, Global development teams and Japan team).
・ The Associate Director of Innovative Medicines Regulatory Affairs in Japan will lead the
document preparation process (incl. Briefing Packages, CTN documents, J-NDA dossier)
to ensure high quality and timely submission as per the agreed workplan.

■Essential Duties & Responsibilities
The Associate Director of Innovative Medicines Regulatory Affairs in Japan will be responsible for the following:
1. Accountable for the development and implementation of regulatory strategies in Japan.
Create proactive and robust regulatory strategies for development products considering the
global regulatory strategy, through the discussion with the Global project team, Global
Regulatory Lead (GRL), Innovative Medicines Regulatory Affairs and Japan team members.
Recommend such strategies to team members and senior management.
2. Lead, implement and drive the regional regulatory strategy & submission activities, including
the planning, coordination and submission of Briefing Packages, meeting requests, CTNs,
J-NDAs and other regulatory filings to ensure compliance with local regulatory standards.
3. Coordinate and lead the team in planning, preparation (incl. Briefing Packages), and
execution for meetings or teleconferences with HAs in Japan.
4. Coordinate responses to HAs with appropriate personnel and departments to resolve
outstanding regulatory issues.
5. Ensure that cross-functional activities to support submissions are in compliance with
regulatory requirements, to achieve timely submissions. Identify gaps and propose/support
solutions to address them that are consistent with regulatory requirements.
Initiation and/or participation in teleconferences and/or meetings related to the topic/project
(to clarify issues, solve issues, discuss changes and strategy, check timelines and
availability of documents, etc.).
6. Represent Innovative Medicines Regulatory Affairs in Japan in global teams (Global
Regulatory Strategy Team (GRST), project team, protfolio/commercial team, etc.) and
provide regulatory filing strategy and guidance in Japan.
7. Assessment of business development opportunities from Japan regulatory perspective.
8. Update internal electronic systems as applicable.
9. Follows all Teva applicable policies and procedures.
10. Other duties as assigned or as business needs required.

■休日：完全週休二日制, 夏季休暇, 年末年始

■Position Requirements
・ Required: BSc/MSc in chemistry/biology/biotechnology/pharmacy or similar scientific field.
・ At least 5 years of experience in regulatory affairs for pharmaceuticals/biologics.
・ Knowledge and actual experiences of interaction with the HAs in Japan, such as consultation meeting and/or J-NDA review.
・ Understanding of the trend and changing regulatory environment surrounding clinical trials in Japan and global. Familiarity with CTD format and ICH requirements for J-NDA filing and clinical development.
・ Ability to strategically apply knowledge across a protfolio of products.
・ Good leadership, project management and communication skills as well as managerial capability.
・ Self-learning & Multi-tasking capabilities.
・ English both spoken and written – business level required.

■職種未経験者：不可