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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.
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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's job description. Free.
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About the Role
This role involves comprehensive CMC regulatory affairs for pharmaceutical products across Europe, North America, and non-Japanese Asian/Arab countries. Responsibilities include strategy development, submission document preparation, responding to regulatory inquiries, and managing post-approval changes.
Responsibilities
- Develop CMC regulatory strategies.
- Prepare CMC submission documents and site registration/update documents.
- Respond to regulatory authority inquiries, including reviewing locally prepared quality documents.
- Evaluate post-approval changes and manage related submissions.
- Assess imported 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 with strong communication and negotiation skills.
Skills
- English proficiency (CEFR B2 or higher).
Location
- Tokyo
- Osaka
- Tokushima
Work Type
- Full-time
Experience Level
- 5+ years
Salary/Compensations
- Based on our company's regulations
Benefits
- Health insurance
- Welfare pension
- Unemployment insurance
- Commuting allowance
- Housing allowance