Career Category

Regulatory

Job Description

Group Purpose

Compliance and Device Regulatory Group performs management and supervision of MAH business license, labeling, FMA, GMP, etc. to contribute to pharmaceutical business execution based on the PMD Act. Lead other activities for compliance with laws and regulations required by the PMD Act. Also, Gr shall plan and draw up development regulatory strategy for Medical Device and CDx, and carry out development in collaboration with external partners.

Job Summary

• Promote and maintain the compliance from the perspective of MAH license under the PMD Act.
• Planning and managing local regulatory submissions related to MAH license, FMA, GMP, etc. in compliance with corporate standards and local regulatory requirements.
• Lead product labeling in premarket development. and post-market activities.
• Act as a contact with regulatory agencies in fulfilling local marketing authorization obligations.
• Assist in aligning local regulatory requirements with Amgen’s corporate standards
• Provide regional input to & execute premarket & post-market regulatory strategies

Key Activities

• Lead and manage MAH and related licenses and activities such as leading Three Supervisors’ Committee (Sanyaku-kai) as secretariate function, establish and maintain required MAH procedures/SOPs, having appropriate and close communication with Tokyo Metropolitan Government (TMG) and MHLW.
• Lead to create M1.8 for Package Insert for the NDA/sNDA and revise PIs, by having PMDA consultations in collaboration with safety and related function.
• Lead and manage to run a process of creation/revision of Package Insert, Package components’ artwork, Instruction for Use, Package Labels/Materials through the label process management system under close communication with Global Labeling Team, supply chain, QA, commercial & marketing and vendors, etc.
• Lead and manage FMA activities to apply and register new accreditations and manage renewal of the accreditations by communicate with MHLW/PMDA.
• Lead and manage HA communications for periodic GMP inspections in collaboration with the Quality team
• Lead and manage to obtain import certificates (Yakkan) through NACCS system and export notification timely.
• Conduct regulatory review of promotional and non-promotional materials for each drug product.

Knowledge and Skills

• Drug business license registration knowledge and experiences in Japan
• Comprehensive and deep knowledge for Pharmaceuticals and Medical Device Affairs Laws
• Expertise for regulatory compliance as post marketing regulatory activities
• Working in matrix environments in Japan and global teams as the One Team
• Communication/involving skills
• English communication – Business level (verbal, read, write)
• IT skills: Outlook/ Word/ Excel/Power Point/Teams, etc. & AI adaption

Education & Experience (Basic)

• Experience to lead M1.8 and Package Insert for the NDA/sNDA and revise regularly in collaboration with Safety management team. (AND/OR) Experience on the services related to Regulatory Compliance (薬制業務) such as MAH license management, regulatory decision making, FMA management, periodical GMP inspection, health authority communications, post marketing regulatory activities, promotional material review, etc.
• Bachelor’s degree and at least 10 years of pharmaceutical industry experiences including at least 5 years in labeling and/or regulatory compliance as above.

Education & Experience (Preferred)

• Knowledge of and experience on Medical Device/IVD regulatory
• Licensed Pharmacist
• Master or Doctor degree

Remarks (Desired character and capability)

• Person who is flexible to change and can actively challenge areas with no experience
• Person who is logical and clear thinker, positive attitude and focusing on problem solving

• A person who can come to the office when necessary for work
• We focus not only on direct experience and knowledge, but also on those with capabilities and potential.

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