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Rezi rewrites your resume against Otsuka Pharmaceutical Co., Ltd.'s job description. Free.
Tailor your resume to this 薬事部 海外CMC薬事室（アジア・欧米CMC薬事担当） role.
Rezi rewrites your resume against Otsuka Pharmaceutical Co., Ltd.'s job description. Free.
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Don't guess if your resume is good enough.
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About the Role
This role involves comprehensive CMC regulatory affairs for product introductions and development stages in Europe, North America, and Asian/Arab countries outside Japan. It includes strategy development, submission document creation, responding to regulatory inquiries, and post-approval change management.
Responsibilities
- Manage CMC regulatory affairs for product introductions and development stages in Europe, North America, and Asian/Arab countries outside Japan.
- Develop CMC regulatory strategies.
- Prepare CMC submission documents and site registration/update documents.
- Respond to regulatory authority inquiries, including reviewing quality documents prepared locally.
- Assess the regulatory impact of post-approval changes and manage related submissions.
- Evaluate introduced products.
Requirements
- Minimum 5 years of experience in pharmaceutical CMC regulatory affairs or related CMC fields (including API/formulation research, production, quality control, quality assurance).
- Proactive and self-motivated.
- Possess strong communication and negotiation skills.
Skills
- English proficiency (CEFR B2 or higher).
Location
- Tokyo
- Osaka
- Tokushima
Work Type
- Full-time
Experience Level
- 5+ years
Benefits
- Comprehensive benefits package
About the Company
- Otsuka is a global healthcare company with a mission to contribute to the health of people worldwide through the creation of innovative products and services.
Equal Opportunity
- Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
- Reasonable accommodation is available for qualified individuals with disabilities or disabled veterans.