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About the Role
Lead regulatory CMC activities for assigned products, ensuring alignment with customer needs and regulatory requirements. Assess and mitigate Japan-specific CMC regulatory risks, and communicate effectively with global functions and health authorities to secure approvals.
Responsibilities
- Lead regulatory CMC activities, including Partial Amendment Applications (PAA), pre-approval GMP/QMS inspections, Foreign Manufacturer Accreditation/Registration (FMA/FMR), Marketing Authorization (MA) Notifications, and Minor Change Notifications (MCN).
- Prepare and review submission documents for assigned products including NDA/PAA/MCN, ensuring alignment with customer needs and regulatory requirements.
- Independently assess Japan-specific CMC regulatory risks, develop feasible regulatory options and mitigation plans, and recommend an appropriate strategy for assigned products.
- Engage in effective communication and/or negotiation with global functions, product supply, external supplier, and health authorities to secure approvals for assigned products.
- Support the development of less-experienced colleagues by providing guidance on regulatory processes, change assessments and CMC regulatory strategies.
Requirements
- University degree or above
- 3+ years of experience in areas of regulatory CMC and change management of marketed products
- Strong understanding of differences between Japanese and global regulatory requirements and processes related to CMC submissions, including familiarity with health authority interactions
- Hands-on experience assessing and implementing a range of post-approval CMC changes
- Proven experience of CMC documentation for submission with excellent working knowledge of current electronic authoring, document management and electronic regulatory submissions
- Solid technical background, knowledge and understanding in at least one CMC technical discipline, e.g. chemistry, formulation, analytical science, or quality assurance
- Ability to prioritize regulatory change management within complex situations influenced by multiple factors, and provide guidance to efficiently execute regulatory change management
- Ability to explain Japan CMC regulatory requirements, risks and recommendations in English and effectively collaborate with global stakeholders to achieve alignment on strategies and actions.
- A proactive, creative mindset that embraces change and drives innovation within the team
- Ability to establish rapport with all key stakeholders with VACC leadership mindset
Skills
- Regulatory CMC
- Change management
- CMC submissions
- Health authority interactions
- CMC documentation
- Electronic authoring
- Document management
- Electronic regulatory submissions
- Chemistry
- Formulation
- Analytical science
- Quality assurance
- Communication
- Negotiation
- Problem-solving
- Guidance
- Japanese
- English
Location
- Tokyo
- Osaka
Work Type
- Regular
- Flexible working hours
- Home-office arrangements
Experience Level
- 3+ years of experience
Education Level
- University degree or above
Salary/Compensations
- Competitive salary package consisting of an annual basic salary and Short-Term Incentive (STI) bonus and top performance award
Benefits
- Various special paid day-offs
- Annual paid vacation days
- Learning and development opportunities through training programs, regular feedback and project participations
- DC pension plan
- Health and medical support by Bayer Health Insurance Association
- Benefit Club membership
- Life insurance
About the Company
- Bayer Pharmaceuticals
Equal Opportunity
- At Bayer, our employees are welcomed, supported, and encouraged to reach their full potential. We also embrace and respect diversity by providing an inclusive and fair work environment for all employees.