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【R&D】Regulatory CMC Development, Regulatory Division (Staff / Individual contributor)

Plats Kita-ku, Ōsaka-fu, Japan Jobb-id R-100950 Datum inlagd 02/25/2021

【職務内容 / Job Description

The position takes major roles for CMC development in Japan in collaboration with Global Pharmaceutical Development (Pharm Dev) and Regulatory CMC.Each staff should keep close communication with responsible functions in terms not only projects which are developed in the Pharm Dev but also general strategy for CMC development for Japan.The role holder should provide CMC contribution to each Therapeutic Areas (TAs).

【経験 / Experience】

<必須 Mandatory>

  • Experience on Drug development or JNDA works
  • Several knowledge drawers on CMC strategies
  • Lot of knowledge to solve CMC issues

<歓迎 Nice to have>

  • Global drug development experience and strong understanding of the wider business in general
  • Have significant number of years experience working within a Pharmaceutical organization
  • Experience of working with external partners
  • Knowledge of JP and other standard codes related to drug and medical device
  • Knowledge of CMC regulations, guidelines (e.g. ICH guidelines) and other license to operate

【資格 / License】

<必須 Mandatory>

  • Graduate the University or Graduate school of pharmacy or other relative science

【能力 / Skill-set】

<必須 Mandatory>

  • Leadership Capabilities
  • Communication and assertiveness
  • Negotiation
  • Logical thinking
  • Writing skill

【語学 / Languages】

<必須 Mandatory>

  • 日本語 Japanese
  • 英語 English: Learn English to attain the smooth communicating level with Global (According to AZKK requirements)

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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