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Regulatory Affairs Manager

年収:1000万 ~ 1200万

ヘッドハンター案件

部署・役職名 Regulatory Affairs Manager
職種
業種
勤務地
仕事内容 Sobi offers the opportunity to work at an international pharmaceutical company
focused on specialty pharmaceuticals on fulfilling the high medical needs of rare
disease patients and providing treatment and services to them. Our employees have
their background in various fields of research, industry and the academic sphere.
The person holding this position will be a professional regulatory support in the
development and maintenance of drug products for our entire organization
We are looking for a Regulatory Affairs Manager - Japan, who will be responsible for
the regulatory work to obtain and maintain marketing authorizations in Japan
through submissions and communication to/with regulatory authorities, for Sobi
Global products. The position can also include work in development projects. The
work requires extensive internal as well as external communication and coordination.
Responsibilities:
 Regulatory Affairs representative in the project teams
 Regulatory responsibility for the products that Sobi Japan handle
 Contact person in relation to authorities, such as PMDA, MHLW (applications, meetings,
etc.)
 Make registration strategy and the plans in stages, based on project progress and
characteristics considering the regulatory compliance
 Be an expert on processes, applications and regulatory environment to achieve and
maintain marketing authorizations
 Provide regulatory advices to global regulatory colleagues and other functional
colleagues considering the Japan regulations
 Work with global regulatory team to ensure regulatory requirement in Japan
 Responsible for registration and maintenance of Marketing Business License, Sales
Licenses, Manufacturing Licenses, and timing of GMP inspections etc.
 Responsible for regulatory assessment of change control
 Responsible for maintenance of Marketing Authorizations of each product, such as
partial change application and minor change notification, etc
 When CROs conduct regulatory activities above on behalf of Sobi, manage their
regulatory activities
 Participate in due diligence as a regulatory representative
応募資格

【必須(MUST)】

Qualifications:
 Degree in Life Sciences or equivalent
 Several years of experience from pharmaceutical industries as a regulatory
representative for new drugs (registration, development, maintenance, etc.).
 Extensive knowledge within Regulatory Affairs, especially for pharmaceuticals in rare
diseases area
 Expertise for CMC knowledge or non-clinical is preferable
 Communication skills, both verbal and written in Japanese and English

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更新日 2022/03/31
求人番号 2120643

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