Regulatory Affairs Mrg (Regulatory Labeling Mrg)
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Career Category
RegulatoryJob Description
Group Purpose
The Compliance and Labeling Group is responsible for MAH business license Three-supervisors committee (Sanyaku-kaigi) Labelling Foreign Manufacturer Accreditation/ Foreign Manufacturer Registration (FMA/FMR) periodic GMP inspection and other activities to ensure compliance the Act on Pharmaceutical and Medical Device(PMD) Act. and to support the execution of the pharmaceutical business.
MAHGMP
Job Summary
- Support the operation of the Three Supervisors Committee (Sanyaku-kaigi) including preparation of materials and meeting documentation.
- Excuse MAH license management and regulatory compliance activities in accordance with the PMD Act.
- Perform labeling-related tasks such as Package Insert (PI) Instructions for Use (IFU) and packaging components.
- Carry out FMA/FMR and GMP-related application and maintenance activities.
- Prepare regulatory submission materials and support communication with health authorities in coordination with internal functions.
- Three Supervisors Committee
- MAH
- PIIFU
- FMAGMP
Key Activities
- Perform MAH-related tasks: preparation and documentation for the Three Supervisors Committee SOP/document management inspection readiness and training support.
- Execute product labeling tasks:
- Support M1.8 creation during development.
- Revise PIs and review promotional materials in post-marketing.
- Support FMA/FMR acquisition and renewal: application registration and communication with MHLW/PMDA.
- Contribute to GMP inspection preparation in collaboration with Quality team.
- Manage package component artwork (PI IFU labels etc.) using an internal system in coordination with Global Labeling Supply Chain QA Commercial/Marketing and vendors.
- Handle import certificates (Yakkan) via Nippon Automated Cargo and Port Consolidated System (NACCS) and export notifications in a timely manner.
- Conduct regulatory review of promotional and non-promotional materials
- MAHSOP
- M1.8
- FMA/FMR/PMDA
- GMP
- PIIFU
Knowledge and Skills
- Practical knowledge of the PMD Act.
- Knowledge and experience in PI IFU and labeling-related operations.
- Basic communication skills for interactions with health authorities (PMDA etc.).
- English proficiency for document preparation and email communication.
- Basic IT skills (business applications document management systems).
- PMDA
- E
- IT
Education & Experience
- Bachelors degree (preferably in a scientific field).
- At least 5 years of pharmaceutical industry experience in regulatory-related activities.
- 5
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the ... View more
