Head of Regulatory Affairs Japan - GDD

Job Description

Head of RA GDD -J is accountable for RA deliverables of NPKK via leadership and oversight of the RA GDDJ team. The Head RA GDD-J reports operationally to the Global Head of RA, GDD RA and functionally to the head of GDD-J.
The Head of RA GDD Japan is the GDD Representative Executive Member in NPKK to Health Authority (PMDA and MHLW).
• Leads all the pre- and post- launch regulatory activities by cooperating with key business partners and relevant divisions in order to keep sustainable product distri-bution.
• Lead the highly competent Regulatory Affairs department in regulatory with keeping credible relationship with Health Authorities e.g. MHLW, PMDA and pharma. industrial Trade associations.
• He/She will build and maintain excellent working relationships with Japanese Health Authorities (PMDA and MHLW and relevant Pharmaceutical Trade Associa-tions, and directs company-aligned regional efforts to influence the external regula-tory environment/policy.
• He/She will drive a culture of country regulatory excellence, and talent development witht o inspire a culture of high collaboration and engagement in RA-Japan
• He/She will be a core member of the RA Global Leadership Team. Participates as RA lead on relevant RA Leadership Teams Forum.
Influencing External Environment: Establish/maintain strong working relationships with senior PMDA/MHLW officials, direct regional advocacy efforts in partnership with internal Novartis advocacy/policy groups, and take country leadership role in representing Novartis on industry associations (e.g.: JPMA; RADAR) and other external forums. Manages the optimal communication of information around Japan regulatory strategy throughout the enterprise and with key external stakeholders. Ensures regulatory assumptions, opportuni-ties and risks are robust, transparent and effectively communicated and that regulatory commitments and deliverables are met.
Portfolio Leadership: Lead the development of innovative and effective regulatory strate-gies to inform product development, regulatory approval and successful commercialization of the pipeline assets in Japan. Direct the development and implementation of Japanese Country regulatory strategies, including proactive identification of regulatory options/risks, ensuring globally aligned negotiation strategies, and ensuring high quality country support for all development compounds (registration) and marketed products (life cycle management) in the Novartis Japanese portfolio.
Lead activities for planned submissions and approvals to achieve targeted labels in time and for post-approval regulatory objectives to secure stable supply of marketed products.
Lead interactions with health authority and deliver regulatory inputs for making best development option in Japan and Strengthen relationship with Japanese health authority and ex-regulators/ex-reviewers as appropriate.
Line Leadership: Maintain strong working relationships with key internal stakeholders in Japan GDD and other local business, line functions/partners key to successfully achieve ob-jectives. Ensure close collaboration across all groups within RA GDD network to support all initial registration and life cycle management actions for RA Japan.

Compliance and Cross-BU Alignment: Responsible for ensuring full compliance with all regulatory obligations / regulations.. Collaborate with other Novartis divisions dealing with HAs such as QA and ensures a consistent regulatory approach as appropriate.

Governance: Advocate continuous improvement of quality and 100% timely delivery of all training requirements including compliance Ensure the Japan RA team will manager adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
Lead activities for post-launched products to avoid any safety/ compliance issue and keep the business well
Chair the Promotion Material Review Committee and supervise the process of promotion material preparation to make sure no deviation from regulation.

People Development: Provide functional, operational and/or local management support to Japanese RA GDD Leaders and colleagues. In collaboration with RA GDD Leadership team, enhance colleague engagement, development and talent management. Serve as role model, and embrace Novartis Values and Behaviors, Strengthen talent and people development to meet the business needs in future, and enhance learning, coaching and mentoring in leaders in RA-J. Create a curiosity, inspired, empowered culture and optimize work-life integration not only RA-J but also GDD-J.

Resource Management: Collaborate with RA GDD Leadership team to ensure resource planning and utilization (FTEs and Budget) for - Japan RAGDD group, seeking to maximize efficiency while ensuring that timelines are met.
Strengthen regulatory intelligence by conducting knowledge-intensive regulatory interactions and proactively transmit latest Japan relevant regulatory information to relevant members.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Education (minimum/desirable): Life Sciences or pharmaceutical in University.
Master degree or Pharmacist license is desirable.
Languages: Fluent Japanese and English as business language

Experience/Professional requirement:  20 years or more experience in pharmaceutical industry, and demonstrate extensive knowledge in regulatory affairs and pharma industry.
 Demonstrated experience coaching and developing people.
 Leadership for enhancing regulatory aspects in company and for effective communication with local (Japan) and global functions broader regional/ global organization.
 Extensive knowledge about HA organization set up including senior members relevant for regulatory licensing actions
 Influential communicator to shape regulatory policy discussions externally (ie. HA/ Trade association)
 Comprehensive overview of the local and global pharmaceutical environment.