Regulatory Strategy Group Manager (Associate Director)

Position Purpose:
The Regulatory Strategy Group Manager is a key leadership position in Japan Regulatory Affairs (RA) who contributes to achieve organizational vision and goals aligning with the strategic objectives of Global Regulatory Affairs (GRA) and R&D Japan.
The Regulatory Strategy Group is responsible for all regional regulatory strategic and operational tasks for a range of development products/projects across all Therapeutic Areas (TAs) in Japan. The Regulatory Strategy Group Manager is accountable and responsible for the group’s performance, leadership and continuous growth.

Reporting Relationships:
This role reports to Head Regulatory Affairs, R&D Japan
Positions reporting into this role: 4 Regulatory Strategy Group members

Main Responsibilities and Accountabilities:
1　The Regulatory Strategy Group Manager strongly supports Head Regulatory Affairs to mange the department and contributes to achieve organizational vision and goals aligning with the strategic objectives of Global Regulatory Affairs (GRA) and R&D Japan.
2　The Regulatory Strategy Group Manager is accountable and responsible for the group’s performance, leadership and continuous growth.
• Establishes and maintains group goals, talent development plan and succession management plan for the group, and guides effective discussion with each group member so that they would establish and execute their own annual performance plan and career development plan.
• Collaborates with GRA Global Product Strategy (GPS) LT members and provides leadership, strategic objectives, and hands-on management to the group members to execute the group role & responsibilities as follows;

2-1. Regulatory Strategy evaluation
The Regulatory Strategy staff (including Japan Regional TA Leads, Senior Experts, Experts, Specialists) develops and executes regional regulatory strategies for valuable outcome collaborating with stakeholders (e.g., Global Regulatory Affair TA Lead, Global Regulatory Leaders, Global Regulatory Affairs CMC Leaders, Japan Project Team members).
• Develops and maintains Japan regulatory strategies (e.g. new drug application, partial change application, clinical trials notification, expedited regulatory application, etc.) considering local requirements, classification of changes, scheduling and priority setting etc., ensuring all regulatory activities are in alignment with the global strategic direction.
• Executes all regulatory activities as agreed strategies and schedules, and oversees they go well.
• Contributes to the development of the Global Regulatory Strategy Overview (GRSO) coping with Global Regulatory Lead by providing regional regulatory strategy.
• Participates in Global Regulatory Affairs Strategy Team (GRAST)/ Japan Project Team (JPT) meetings to provide valuable insights as Japan regulatory expertise.

2-2. Regulatory Strategy dossiers
The Regularory Strategy staff oversees the compilation of relevant high-quality documentation for submissions in Japan, including new drug applications, partial change applications, expedited regulatory applications like orphan drug designations etc., clinical trial notifications, according to agreed schedules while taking into account local specific requirements.
• Ensure that dossiers meet the content and format requirements for the regional regulatory authorities via effective communication with the related GRA members
• Based on submission overviews, takes certain responsibilities for preparation and compilation of regional parts of submission packages, e.g. some Modules 1 and 2 sections, including application form.
• Provides timely and high-quality responses to Health Authority questions.

2-3. Health Authorities Consultations
The Regulatory Strategy staff prepares materials for negotiations, meetings, and consultations with Japanese Health Authorities.

2-4. Regulatory Strategy oversight
The Regulatory Strategy staff oversees and interprets relevant existing or new regulatory requirements, evaluates draft guidelines, makes impact assessments, leads gap analysis, and proposes solutions and strategies to remediate risks.

2-5. Subject Matter Experts
The Regulatory Strategy staff acts as a Subject Matter Expert on regional, regulatory procedures and HA requirements.
• Is the primary contact point interfacing with Global Regulatory Leaders, relevant internal and external parties, regulatory agencies for project planning purposes, compilation, and updates of technical documentation and for addressing regulatory questions.
• Is a permanent member of the GRAST.
• Is a permanent member of the JPT.

2-6. External Engagement
The Regulatory Strategy staff develops and maintains effective working relationships with the Japanese HAs and external stakeholders (e.g. industry associations like PhRMA-Japan, EFPIA-Japan etc.) demonstrated by high quality communication and effective use of negotiation skills to achieve positive outcomes for CSL.

2.7 Technical support culture
The experienced Regulatory Strategy staff (especially Japan Regional TA Leads, Senior Experts) provides technical guidance to developing other group members and support them for organizational values and operational excellence.

2.8. Organizational support culture
The experienced Regulatory Strategy staff (especially Japan Regional TA Leads, Senior Experts) strongly supports the Regulatory Strategy Group Manager to manage the group so that organizational objectives and goals can be achieved. The experienced Regulatory Strategy staff may possibly act as a deputy of the group manager in the specific situation.

Job Qualifications and Experience Requirements:
Education
Bachelor’s degree in a Life Science. Advanced degree in a Life Science (MSc, PhD, MD) or Business Administration (MBA) preferred

Experience
At least 15 years of regulatory affairs and/or other R&D functions in pharmaceutical companies.
At least 10 years of regulatory development experience for development products such as new drug application, partial change application, expedited regulatory application, clinical trial notification, PMDA consultation etc.
People leader’s experience preferred

Competencies
• Japanese and global regulatory legislation knowledge
• Microsoft Office skills
• Regulatory specific systems skills (e.g. RIMS, FD application)
• Fluent Japanese and English communication skills (both written and spoken)
• Empathy with CSL values: Patient Focus, Innovation, Integrity, Collaboration, Superior Performance

Leadership Capabilities
o Think Beyond: Thinks beyond our own business, beyond our own borders, beyond what is familiar, and beyond today. Helps teams respond to the external environment.
o Build Bridges: Models and Encourages collaboration and integration, across the business and around the globe. Proactively improves cross-business collaboration.
o Unleash Outcomes: Responds to challenges with urgency and action, whether that’s operating at peak efficiency, delivering safety and quality for patients, or innovating for growth. Empowers team member accountability and decision making.
o Ignite Agility: Be flexible, resilient, and able to lead effectively through change. Leads effective organizational change.
o Inspire the Future: Be visionary, creating high levels of confidence and energy across the company. Ensures teams buy into the strategy.
o Cultivate Talent: Be relentlessly focused on developing

Our Benefits

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About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .

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As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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