薬事担当シニアマネージャー/ Senior Manager, Regulatory Affairs

A global pharmaceutical development company is looking for a Senior Manager, Regulatory Affairs. The selected candidate will lead regulatory strategies and documentation efforts while collaborating closely with global teams. This is a remote role.

Responsibilities:

• Represent the company in negotiations with PMDA and MHLW
• Conduct regulatory assessments and provide strategic input
• Collaborate with Global PRA teams and external clients
• Offer regulatory guidance and align internal departments with local requirements
• Lead the preparation of regulatory documents such as clinical trial notifications
• Mentor and support the development of junior team members

Requirements:

• Bachelor’s degree or above in a scientific domain
• Experience in development regulatory affairs (dealing with authorities, submission work)
• Prior experience negotiating/communicating with regulatory authorities
• Proven experience in global clinical trials
• Proficient in MS Office Suite
• Business level written and spoken English

About the Company:

A leading global provider of clinical research and healthcare intelligence services, this company specialises in delivering innovative solutions that accelerate drug development and improve patient outcomes. With a strong presence in Japan, it offers a dynamic environment for professionals passionate about transforming clinical trials through data-driven insights and medical expertise.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系, 大阪 求人

Job Ref: 35JW45