[Innovative Medicine] R&D 薬事統括部 開発薬事部 開発薬事グループ マネージャãƒ

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 https://www.jnj.com

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-CDT
➢ May serve as a regulatory lead at J-CDT
➢ 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-CDT
➢ 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 ...