RA (コンプライアンスラベリング)/ RA (Compliance Labeling)

A multinational biopharmaceutical company is seeking an RA Compliance Labeling professional. The selected candidate will support regulatory compliance activities, manage labelling processes, and coordinate submissions and communication with health authorities.

Responsibilities:

• Support operation of the Three Supervisors Committee including preparation of materials and meeting documentation
• Perform MAH-related tasks including documentation, SOP management, inspection readiness and training support
• Execute product labelling tasks including support for M1.8 creation during development
• Revise package inserts and review promotional materials in post-marketing
• Support FMA and FMR acquisition and renewal including application, registration and communication with authorities
• Contribute to GMP inspection preparation in collaboration with the quality team
• Manage package component artwork including PI, IFU and labels using internal systems in coordination with cross-functional teams and vendors
• Handle import certificates via NACCS and manage export notifications in a timely manner
• Conduct regulatory review of promotional and non-promotional materials
• Prepare regulatory submission materials and support communication with health authorities

Requirements:

• Bachelor’s degree or above in a scientific field
• More than 5 years of experience in pharmaceutical industry regulatory-related activities
• Practical knowledge of the PMD Act
• Knowledge and experience in PI, IFU and labelling-related operations
• Basic communication skills for interaction with health authorities
• Basic IT skills including business applications and document management systems
• Proficient in English

About the Company:

A global pharmaceutical group, this organisation is an internationally recognised name in biotechnology. Responsible for a range of medicines aimed at treating human illnesses, this company supplies medical professionals and patients across the world.

Keywords:

薬事, ラベリング, 医薬品規制, 添付文書, 規制対応, 承認申請, 医薬品業界, 求人, 外資系

Job Ref: IT4C2W