Regulatory CMC Expert (manager), Japan

Position Purpose:

• The Regulatory CMC Expert evaluates all CMC regulatory aspects related to the assigned products (including both development products and established products) in Japan.
• The Regulatory CMC Expert develops and executes CMC strategies for development products/life-cycle management of established products collaborating with team members (e.g. Global Regulatory Leaders Global Regulatory CMC Regional Regulatory Representative).
• The Regulatory CMC Expert prepares CMC regulatory dossiers (e.g. Japanese CTD) for development products and/or established products based on the global CMC documents (e.g. M3 documents /reports) in accordance with Japanese regulations and requirements.
• The Regulatory CMC Expert prepares materials for negotiations meetings and consultations with Japanese Health Authorities for development products and/or established products.
• The Regulatory CMC 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.
• The Regulatory CMC Expert acts as a Subject Matter Expert on regional regulatory procedures and HA requirements.
• The Regulatory CMC Expert develops and maintains effective working relationships with the Japanese HAs demonstrated by high quality communication and effective use of negotiation skills to achieve positive outcomes for CSL Behring.
• The Regulatory CMC Expert provides technical guidance to local CMC specialists and supports them for organizational values and operational excellence.

Reporting Relationships:

This role reports to:

Regulatory CMC Group Manager Regulatory Affairs R&D Japan

Positions reporting into this role: NA

Main Responsibilities and Accountabilities:

1 The Regulatory CMC Expert evaluates all CMC regulatory aspects related to the assigned products (including both development products and established products) in Japan.

• Evaluates the available technical and scientific CMC information for compliance with regulatory requirements performs gap analysis and proposes solutions and strategies to remediate risks.
• Provides or supports timely and compliant regulatory assessments as well as efficient execution of CMC changes.

2 The Regulatory CMC Expert develops and executes CMC strategies for development products/life-cycle management of established products collaborating with team members (e.g. Global Regulatory Leaders Global Regulatory CMC Regional Regulatory Representative).

• Takes part in the development of regulatory CMC strategies considering the applicable submissions based on the scientific justification regional requirements and the schedule.
• Makes scheduling and prioritization of CMC related submissions.
• Contributes to the development of the Global Regulatory Strategy Overview (GRSO) coping with Global Regulatory CMC by providing regional CMC strategy.
• Participates in Global Regulatory Affairs Strategy Team (GRAST)/ Japan Project Team (JPT) meetings in charge.

3 The Regulatory CMC Expert prepares CMC regulatory dossiers (e.g. Japanese CTD) for development products and/or established products based on the global CMC documents (e.g. M3 documents /reports) in accordance with Japanese regulations and requirements.

• Ensures that dossiers meet the content and format requirements for the Japanese HAs.
• Based on submission overviews takes certain responsibilities for preparation and compilation of regional parts of CMC submission dossiers e.g. CTD CMC parts including application form.
• Provides timely and high-quality responses to CMC related Health Authority questions.

4 In accordance with Global strategy the Regulatory CMC Expert prepares materials for negotiations meetings and consultations with Japanese Health Authorities for development products and/or established products.

5 The Regulatory CMC 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.

6 The Regulatory CMC Expert acts as a Subject Matter Expert on regional regulatory procedures and HA requirements

• Is the primary contact point interfacing with GRA CMC relevant internal and external parties regulatory agencies for project planning purposes compilation and updates of technical documentation and for addressing CMC regulatory questions.
• Is a permanent member of the Global Regulatory Affairs Strategy Team (GRAST) and/or of the relevant CMC Regulatory Sub-Team.
• Is a permanent member of the Japan Project Team (JPT)

7 The Regulatory CMC Expert develops and maintains effective working relationships with the Japanese HAs demonstrated by high quality communication and effective use of negotiation skills to achieve positive outcomes for CSL Behring.

8 The Regulatory CMC Expert provides technical guidance to local CMC specialists and support them for organizational values and operational excellence.

Position Qualifications and Experience Requirements:

Education

Bachelors degree in a Life Science. Advanced degree in a Life Science (MSc PhD MD) or Business Administration (MBA) preferred

Experience

At least 5 years pharmaceutical industry experience in CMC either in RA and/or QA etc.
At least 3 years of Regulatory CMC experience for development and/or established products and regulatory activities such as J-NDA PCA and/or MCN.

Competencies

• Japanese regulatory legislation expertise
• Microsoft Office skills
• Fluent Japanese and English communication skills (both written and spoken)
• Empathy with CSL values: Patient Focus Innovation Integrity Collaboration Superior Performance
• Leadership Capabilities
  • 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.
  • Build Bridges: Models and Encourages collaboration and integration across the business and around the globe. Ensures teams are set up for collaboration.
  • Unleash Outcomes: Responds to challenges with urgency and action whether thats operating at peak efficiency delivering safety and quality for patients or innovating for growth. Creates an accountable working environment.
  • Ignite Agility: Be flexible resilient and able to lead effectively through change. Instills personal flexibility in self and teams.
  • Inspire the Future: Be visionary creating high levels of confidence and energy across the company. Ensures clarity around the strategy.
  • Cultivate Talent: Be relentlessly focused on developing tomorrows talent today. Hires and coaches effectively.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

You Belong at CSL

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit Experience:

Manager