Sr. Scientist, Regulatory Liaison
Lead Consulting Group Tokyo, Japan
- Posted on
- Oct 11, 2021
- Job type
- Full-time
- Career level
- Mid career
- Industry
- Pharmaceutical
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Job Description
Sr. Scientist, Regulatory Liaison
Job Description
- Develop an efficient and high value-added Japan regulatory development strategy in line with global strategies
- Responsible as a contact person with regulatory authorities (MHLW and PMDA, etc.)
- Contribute to improving documents quality submitted by authorities through review on CTD, PMDA consultation documents, responses to inquiries, etc.
- Coordination of preparation and submission of NDA, PMDA consultation, responses to inquiries, etc.
- Collection and analysis of regulatory information on NDA etc. and sharing to relevant parties
- Coordination including HQ when interacting authorities (30-days review, PMDA consultation, NDA submission, NDA review)
Required Qualifications
<History and experience>
- Experience working at a pharmaceutical company or company related to pharmaceutical development
- Filing/Review experiences
- Master of Life Sciences or above
<Knowledge / Skill>
- Basic knowledge about pharmacy or medicine
- English skill at a level capable of reading English literature and communicating by email with overseas
- Communication skills
Desired Qualifications
<Thinking / action>
- Positive
- Logical thinking
- Initiative / action type
- Skills
- new business development, key account management, b2b, biotechnology, drug development, sales operation
- Education level
- Bachelor's Degree
- Japanese Level
- Native/Fluent
- English Level
- Native/Fluent
- Annual Income
- ¥8M - 12M
- Job benefits
- Housing allowance and flexible working hours
- Welfare Benefits
Social insurance and other benefits
- Vacation Holidays
Japanese holidays and Annual leave
Location
HIGASHISHIMBASHI (TSUGINOBIRUONOZOK, Minato-ku105-0021 Tokyo, Japan
English and Japanese
70% to 30%
Friendly
We offer work life balance
Lead Consulting Group
Pharmaceutical
Tokyo, Japan
About Us
Lead Consulting Group is an executive recruitment consultancy company based in Japan.We work closely with multinationals, midsize to small companies, governments, and educational institutions in the areas of human capital management and related services.
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