[Innovative Medicine] R&D, Specialist/Manager, Regulatory Strategy & Liaison Group, Regulatory Devel

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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 Wo...