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 content, scope and timing
Provides input to and reviews submission documents to ensure they accurately answer the questions being posed and are consistent with HA commitment for Japan
Support cross-functional team to respond 30 (14) Day review and amendment for J-CTN

Response to HAs
Lead strategy for providing responses to PMDA/MHWL questions (ensure alignment with global strategy by collaboration with responsible function for the topic)
Ensures that responses to PMDA/MHLW questions are handled in a timely manner and in line with the approved product strategy
Lead cross-functional team (CTD Preparation Team) to prepare HA responses.
Participates in J-PT/CTD Preparation Team to ensure appropriate and timely responses to HA questions. Provides clarification regarding HA questions and provides input to the strategy for responding to HA questions

Relationship with Global Team
Participates in project related GRT meetings by providing Japanese input if required
Participates in CDT meeting to provide input on Japanese regulatory strategy if required
Communicate with Global Regulatory Leader / APRA Liaison to exchange information
Interacts with APRA Liaison to facilitate execution of regulatory strategy (e.g. for co-development with Asia-Pacific countries) 

Regulatory Advice
Supports all regulatory activities associated with the registration and maintenance of new products and line extensions (e.g. additional indications)
Provides guidance and support to J-CDT on regulatory issues
Exchanges information on Japanese regulation with appropriate person, e.g. GRL, APRA liaison

RA Organizational Management
Participates in Regulatory Development Department ext-LT to discuss and manage issues/improvement related to department and RCL work
Support RA Professionals

REPORTING RELATIONSHIPS:
JAPAN Regulatory Affairs: Sr Manager, Japan RA TA Leader / Director, Japan RA TA-Group Leader
Global: Global Regulatory Leader