Description

POSITION SUMMARY:

• Lead Japanese regulatory strategy and target labeling in JCoT, and share the information to the Global Regulatory Team (GRT)
• Lead CTD Preparation Team for J-NDA submission
• Lead HA response such as PMDA consultation/ preliminary meeting, MHLW meeting for orphan designation, 30 (14) Day review for J-CTN regarding Development plan and submission
• 　   Negotiate with Japanese Health Authorities (HA) regarding development compound 

PRINCIPAL RESPONSIBILITIES:

Input regulatory strategy to JCoT

• May serve as a regulatory lead at JCoT
• Participates in GRT to provide input 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 JCOT
• 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 CTN 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
• Provides input for Japanese Target Label
• Negotiates Japanese labeling with HA, going through each of the back-up strategies if necessary
• Ensure the Target Label and Labeling Strategy conforms to the Regulatory Strategy for Japan
• Drive Japanese Labeling Strategy development and backup strategies for label negotiation
• 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

CTA/NDA Preparation & submission

• Provide input to and be accountable for the preparation of dossiers for submission to HA (NDA /CTA)
• 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 JCT to define submission plans including timing for new CTA and CTA 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 (JCT) to respond 30 (14) Day review and amendment for J-CTN

Response

• 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 JCOT/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 TC as AdHoc-CDT for Japan to provide input on Japanese regulatory strategy
• Communicate with Global Regulatory Leader / AP&LA Liaison to exchange information
• Interacts with AP & LA Liaison to facilitate execution of regulatory strategy (e.g. for co-development with Asia-Pacific countries)
• Exchange information with Asia Pacific Regional Regulatory Office (e.g. on co-development with Asia-Pacific countries)

Interactions with HA

• Works with regulatory agencies on a daily basis, and leads and/or participates in other meetings with Japanese regulatory agencies as appropriate.

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 Japan product development teams on regulatory issues
• Exchanges information on Japanese regulation with appropriate persons; e.g. GRL/ AP liaison

RA Organizational Management

• Participates in Regulatory Development Department ext-LT to discuss and manage issues/improvement related to department and RCL work
• Support non-manager RCLs

REPORTING RELATIONSHIPS: 

JANSSEN JAPAN: Group Leader / RA director

Global: Global Regulatory Leader / AP Liaison

Qualifications

EDUCATION, EXPERIENCE & SKILL REQUIREMENTS:

• Minimum of bachelor’s degree or equivalent in pharmacy or life-science or health-related discipline
• Minimum of 6 years of overall experience in R&D in pharmaceutical industry (including 2+ years of regulatory experience) or in health authorities OR Masters/PharmD  and 4+ years, PhD and 2+ years
• Leadership and contribution to drug development strategies
• Experience in HAs interactions
• Knowledge of regulations in Japan
• Good verbal and written communications skills in Japanese and business-level English skills
• Can develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor.
• Proactive team player, able to take charge and follow-through.  Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
• Flexibility to accommodate early morning/evening meetings/ teleconferences with different time zones, especially if there is an important topic related to Japan development plan.

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