Sr. Scientist, Regulatory Liaison

Lead Consulting Group Tokyo, Japan

Posted on
Mar 5, 2021
Job type
Full-time
Career level
Mid career
Industry
Pharmaceutical

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
Sales, business development, new business development, key account management, sales operations, b2b, account management, sales process, biotechnology, drug development
Education level
Bachelor's Degree
Japanese Level
Fluent
English Level
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

Higashi Shimbashi Building 2-10-10
HIGASHISHIMBASHI (TSUGINOBIRUONOZOK, Minato-ku
105-0021 Tokyo, Japan

Remarks

Experience in Internet and software is a plus

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 in Japan.

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