Job Description Summary
• Responsible for CMC-related regulatory affairs activities to obtain regulatory approval for biosimilars in Japan.• Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities (HA).
• Interaction with HA on REG CMC questions to make new products and/or post marketed products successful.
Job Description
Major accountabilities:
- Lead CMC regulatory strategy with a focus on maximizing the business benefit balanced with regulatory compliance
- Lead submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
- Experience and capabilities are required to personally perform new submission and post-marketed products.
- Lead the submission by identifying required documents/ potential risks which could affect the defied timeline, by assessing content and quality, etc, and by completing the application on time in line with a Global team–aligned project plan to obtain regulatory approval.
- Authoring and reviewing high-quality RA CMC documentation for HA submission, ensuring alignment with applying agreed CMC global regulatory strategies and current regulatory trends and guidelines.
- Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate.
- Initiate and lead HA interactions and negotiations as appropriate; setting objectives, preparing/reviewing briefing books, coordinating and planning rehearsals and risk mitigation plans.
Key performance indicators:
- Coordinate with Global and Japan stakeholders to prepare high-quality RA CMC documentation and presentations, and lead regulatory activities including HA consultations, submissions, and change management.
- Ensure RA CMC documentation complies with current regulatory requirements and Sandoz internal guidelines.
- Provide timely regulatory assessments and strategic advice, particularly for change management, to ensure regulatory compliance.
- Maintain effective working relationships with internal (Japan and Global) and external stakeholders.
Minimum Requirements:
Work Experience:
- Operations Management and Execution
- Cross-functional collaboration
Skills:
- Preparation of RA CMC-related documents for biosimilar marketing authorization applications
- Change Control
- Cross-Functional Teams
- Documentation Management
- Negotiation Skills
- Project Management
- Regulatory Compliance
- Risk Assessment
- Risk Management
Languages :
- English and Japanese
Skills Desired
Change Control, Cross-Functional Teams, Documentation Management, Negotiation Skills, Regulatory Compliance, Risk Assessment, Risk Management, Waterfall Project Management
What We Do
Sandoz is the global leader in generic and biosimilar medicines. Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance. We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.
