Senior Regulatory Strategy Expert (Senior Manager)

Position Purpose:
Senior Regularory Strategy Expert is responsible for all regional regulatory strategic and operational tasks for a range of development products/projects in the assigned TAs in Japan.
The Senior Regularory Strategy Expert also provides technical guidance to other Regularory Strategy members (especially, lower job grade experts like managers or associate managers) and supports them for organizational values and operational excellence.

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

Main Responsibilities and Accountabilities:
1 The Senior Regularory Strategy Expert 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 The Senior Regularory Strategy Expert 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.

3 The Senior Regularory Strategy Expert prepares materials for negotiations, meetings, and consultations with Japanese Health Authorities.

4 The Senior Regularory Strategy Expert 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.

5 The Senior Regularory Strategy Expert 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.

6 The Senior Regularory Strategy Expert 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.

7 The Senior Regularory Strategy Expert also provides technical guidance to other Regularory Strategy members (especially, lower job grade experts like managers or associate managers) and supports them for organizational values and operational excellence.

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 7 years of regulatory affairs and/or other R&D functions in pharmaceutical companies.
At least 5 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.

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. Maintains an external and strategic focus for self and team.
o Build Bridges: Models and Encourages collaboration and integration, across the business and around the globe. Ensures teams are set up for 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. Creates an accountable working environment.
o Ignite Agility: Be flexible, resilient, and able to lead effectively through change. Instills personal flexibility in self and teams.
o Inspire the Future: Be visionary, creating high levels of confidence and energy across the company. Ensures clarity around the strategy.
o Cultivate Talent: Be relentlessly focused on developing tomorrow’s talent today. Hires and coaches effectively.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

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.

We want CSL to reflect the world around us

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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