募集要項
- 募集背景
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Overview:
Responsible for defining regulatory strategies and submissions in support of new and existing marketing authorizations for products for one or more countries. Typically, will supervise or mentor more junior employees.
- 仕事内容
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Key Responsibilities:
● Develop and execute regulatory strategies/ plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations
● Lead the RA function on assigned cross-functional project teams
● Monitor applicable regulatory requirements; assure compliance with the company and external standards
● Establish appropriate communication within RA and other functions at the project level and to senior management
● Perform gap analysis and propose solutions
● Develop and document sound regulatory decisions and justifications
● Ensure project teams, business objectives and deliverables, and regulatory strategy are aligned
● May provide direct supervision of individuals
● May review promotional material or SOP’s for compliance with local and global regulations
- 応募資格
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- 必須
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Qualifications:
● Sound basis of Regulatory knowledge in general
● Experience in creating and managing Class IV device submissions
● Sound basis of Regulatory knowledge in country of interest
● Scientific Knowledge – ability to understand Advanced Surgery products and uses
● Ability to manage complex projects and timelines in a matrix team environment
● Strong oral and written communication and presentation skills – ability to work closely and effectively with the Global RA and project teams.
● Demonstrated interpersonal skills including strong negotiation skills
● Ability to independently identify compliance risks and escalate when necessary
● Ability to lead and coach others – internal and external partners
Education & Experience:
● Bachelor’s degree or country equivalent in related scientific discipline with a minimum of 10 years regulatory experience in RA or related field, including managing people or projects.
● Higher degree/PhD will be an advantage. Ability to communicate effectively using Japanese and English.
- 雇用形態
- Full-Time/正社員
- ポジション・役割
- Regulatory Affairs Manager - Advanced Surgical
- 勤務地
- Saitama Prefecture / Chiba Prefecture / Tokyo / Kanagawa Prefecture
- 年収・給与
- 11 million yen ~ 12.99 million yen