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渋谷区, 日本
Onsite
Job title: Senior Manager, Regulatory Affairs
Location: Hatsudai Tokyo
Position Summary
The Senior Manager, Regulatory Affairs serves as the Japan regulatory lead for assigned development projects. This role is responsible for formulating and executing Japan regulatory strategies in alignment with global development plans, leading PMDA interactions, and ensuring high‑quality regulatory submissions including CTNs, J-NDAs, and J-sNDAs.
As a senior regulatory expert, the individual will provide strategic input to cross‑functional teams, guide regulatory risk assessment and mitigation, and contribute to the successful and timely delivery of medicines to patients in Japan.
Role & Responsibilities
Develop and implement Japan regulatory strategies for development programs and new indications, ensuring alignment with global regulatory strategies.
Serve as the regulatory representative on project teams, providing expert guidance on Japan regulatory requirements.
Lead preparation and execution of PMDA Consultation Meetings and Health Authority interactions, including development of meeting scenarios and briefing documents.
Identify regulatory risks and develop mitigation plans; ensure timely communication and alignment across stakeholders.
Represent Japan regulatory perspectives within global regulatory teams (GRT) and contribute to global strategy development.
Lead the preparation and internal review coordination of Japanese CTD (J‑CTD) modules for major submissions (CTN, J‑NDA, J‑sNDA).
Coordinate cross‑functional contributions from non‑clinical, clinical, medical, PV, CMC and other key stakeholders.
Lead preparation of responses to PMDA inquiries and ensure high‑quality, timely submissions.
Lead Japanese Package Insert revisions requested by Commercial or Medical teams, when handled by PMDA’s New Drug Review Division.
Ensure compliance with Japan regulatory requirements and internal quality standards for all submissions and regulatory documents.
Act as a key point of contact for PMDA and MHLW for assigned products.
Build and maintain constructive relationships with regulatory authorities and relevant external stakeholders.
Demonstrate behaviors aligned with the company’s values and contribute to a collaborative, positive, and learning‑oriented team culture.
Encourage junior staff to proactively learn, challenge assumptions, and adopt a problem‑solving mindset.
Knowledge, Skills & Competencies / Language
Hands-on experience with CTN preparation, PMDA consultations, and regulatory submissions (preferred but not mandatory at entry level for this grade).
Knowledge of the drug development process and Japan regulatory review frameworks.
Experience with CTD/eCTD preparation is preferred.
Strong logical and analytical thinking.
Excellent negotiation and communication skills.
Ability to proactively identify issues and drive solutions.
Demonstrated ability to work independently with a positive and self‑driven mindset.
Strong cross‑functional collaboration skills and ability to influence without authority.
Results-oriented and persistent in achieving goals.
Highly organized with strong attention to detail.
Qualifications
Bachelor’s degree or higher in a scientific or health-related field (advanced degree preferred).
Minimum 2 years of experience in R&D functions or regulatory affairs within the pharmaceutical industry or equivalent.
Business-level English (TOEIC 800+ or equivalent).
Native-level Japanese required.
As a regulatory expert, you will be a core member of cross‑functional project teams and directly influence development strategy and key decision-making.
The role offers the opportunity to engage closely with PMDA on development plans and scientific discussions, one of the most impactful and rewarding aspects of regulatory affairs.
You will gain firsthand insight into evolving regulatory frameworks, new guidelines, and emerging trends in Japan’s development landscape, continuously strengthening your expertise.
This role contributes directly to accelerating patient access to innovative therapies in Japan, providing a strong sense of purpose and mission.
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