Job Title:
Associate Director Regulatory Affairs
Type:
Permanent, full-time
Location:
Tokyo, Japan (hybrid)
The opportunity
- 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 (CTN, PMDA consultation, J-NDA dossier preparation and filing).
- Need a strong communication skills and built excellent trust-based relationship with health authorities ( MHLW, PMDA) and with various internal stakeholders
- Lead the document preparation process (including Briefing Packages, CTN documents, J-NDA dossier) to ensure high quality and timely submission as per the agreed workplan.
How you'll spend your day
- 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.
- 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.
- Coordinate and lead the team in planning, preparation (including Briefing Packages), and execution for meetings or teleconferences with health authorities in Japan.
- Coordinate responses to health authorities with appropriate personnel and departments to resolve outstanding regulatory issues.
- 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.
- Provide regulatory filing strategy and guidance in Japan.
- Assessment of business development opportunities from Japan regulatory perspective.
- Update internal electronic systems as applicable.
Your experience and qualifications
- BSc/MSc in chemistry/biology/biotechnology/pharmacy or similar scientific field
- 5+ years of experience in regulatory affairs for pharmaceuticals/biologics
- Knowledge and actual experiences of interaction with the health authorities 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 globally. Familiarity with CTD format and ICH requirements for J-NDA filing and clinical development
- Good leadership, project management and communication skills as well as managerial capability
- Japanese
both spoken and written – business level required
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