# [Innovative Medicine] R&D, Specialist/Manager, Regulatory Strategy & Liaison Group, Regulatory Development, Regulatory Affairs at Johnson & Johnson

Johnson & Johnson is hiring a [Innovative Medicine] R&D, Specialist/Manager, Regulatory Strategy & Liaison Group, Regulatory Development, Regulatory Affairs in Tokyo, Japan. Level rates it Little AI ●○○○; you can [apply on Johnson & Johnson](https://jobsbylevel.com/go/0b818139-a4c2-4bc0-a108-29f0e696f694?utm_medium=ai-agent).

AI Level 1, AI centrality 0 out of 100. Chiyoda, Tokyo, Japan.

## Details

- Company: [Johnson & Johnson](https://jobsbylevel.com/companies/johnson-johnson)
- AI level: AI Level 1 (score 0 out of 100)
- Location: Chiyoda, Tokyo, Japan
- Posted: August 24, 2026
- Apply: https://jobsbylevel.com/go/0b818139-a4c2-4bc0-a108-29f0e696f694?utm_medium=ai-agent
- Free CV review for this job: https://jobsbylevel.com/cv-review?job=innovative-medicine-r-d-specialist-manager-regulatory-strategy-liaison-group-regulatory-development-regulatory-affairs-at-johnson-johnson-c00df8

## Prepare for this job

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## Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Chiyoda, Tokyo, Japan Job Description: POSITION SUMMARY: Lead Japanese regulatory strategy and target labeling in J-CDT, and share the information to the Global Regulatory Team (GRT) Lead CTD Preparation Team for J-NDA submission Lead Japanese Health Authority (HA) response such as PMDA consultation/ preliminary meeting, MHLW meeting related the development of compound, 30 (14) Day review for J-CTN regarding development plan and submission Negotiate with HAs regarding development compound PRINCIPAL RESPONSIBILITIES: Input regulatory strategy to J-PT May serve as a regulatory lead at J-PT Participates in GRT to provide inputs on Japanese regulatory strategy and target labeling Refines Japanese regulatory strategy as new data becomes available and re-assesses as necessary Provides input into strategy with respect to clinical study design for local studies. (Provides input into global clinical studies with Japanese requirement if needed) Develops and updates contingency plans for regulatory strategies as they pertain to Japan Provides input on implications for regulatory strategy through participation in J-PT Reviews and provides regulatory input on Japanese Investigator Initiated Proposals as required Within the context of the global strategy, determines timing, appropriate Japanese strategy and content for Japanese HA meetings of development products. Provides input on study design, conduct, and need for any additional studies for Japan Provides regulatory strategic and operational support for products by interacting with project teams, reviewing protocols, maintaining CTNs and NDAs (prepare and submit regulatory submissions, protocol amendments, etc) etc. Write and revise disease-specific Japanese target labels based on attributes from Japanese Target Product Profile (TPP) and linked to the Clinical Development Plan and the Regulatory Strategy for Japan Labeling Co-lead the Japanese Labeling Working Group in making strategic decisions, including creation of Labeling strategy Reviews labeling to ensure adequate documentation supports the Japanese labeling text Ensure the target label and labeling strategy conforms to the Regulatory Strategy for Japan Responsible for the contribution to development of Japanese labeling strategy and backup strategies for label negotiation for Japan Write and revise Japan target labels during development that are aligned to clinical, commercial and regulatory strategies and in response to evolving data CTN/NDA Preparation & submission Provide input to and be accountable for the preparation of dossiers for submission to HA (NDA /CTN) Lead the CTD Preparation Team to prepare Common Technical Document (CTD) for Japan Defines, generates and submits appropriate data-driven responses to Japanese HA questions Manages lifecycle management submissions for additional indication etc. / with clinical study for Japan. Provides input to J-CT to define submission plans including timing for new CTN and CTN amendments and HA reporting requirements; CTN submission dossier

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Source: https://jobsbylevel.com/jobs/innovative-medicine-r-d-specialist-manager-regulatory-strategy-liaison-group-regulatory-development-regulatory-affairs-at-johnson-johnson-c00df8

## Cite this page

Level. https://jobsbylevel.com/jobs/innovative-medicine-r-d-specialist-manager-regulatory-strategy-liaison-group-regulatory-development-regulatory-affairs-at-johnson-johnson-c00df8.

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