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CMC RA Scientist at Global Biopharma

Tokyo 23 Wards Permanent ¥8,000,000 - ¥14,000,000 per year Foreign Multinational View Job Description
Take lead in CMC RA submissions and development strategy to obtain product approval. Prepare CMC documentations and management of post-approval CMC.
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  • One of the leading global biopharma taking the forefront in innovative products
  • Take lead in CMC RA development and applications to obtain product approval

About Our Client

  • Global leading pharmaceutical company leading in biologics
  • Rich development pipeline for various unmet medical needs
  • Flexible working hours as well as predominately remote option
  • Flat organisation with global working style
  • Extensive collaboration with external/global stakeholders

Job Description

  • Take lead in all CMC RA activities for the business
  • Provide input in RA strategy from a CMC point of view
  • Preparing maintaining of DMF, FMA, ensuring CTN/IMP documents
  • Creating and submitting CMC CTD dossiers of biologic products
  • Communicate with PMDA and other health authorities

The Successful Applicant

  • University degree in a scientific or related field
  • Experienced in RA field in CMC for the pharmaceutical or CRO industry
  • Background in DMF, FMA, IMP handling
  • Fluency in English and Japanese (Non-native level speakers will not be selected)
  • Ability to work in a hands on working environment

What's on Offer

  • Competitive salaries and benefits
  • Great work life balance and flexible working hours
  • Amazing career progression in the RA field
  • Ability to work independently as well as extensive communication with various stakeholders
  • Work with industry leaders who are solving various unmet medical needs
  • Global working environment
Contact
Zach Itozu
Quote job ref
JN-082023-6154062
Phone number
+813 6832 8683

Job summary

Function
Life Sciences
Specialisation
Regulatory Affairs
What is your area of specialisation?
Healthcare / Pharmaceutical
Location
Tokyo 23 Wards
Job Type
Permanent
Consultant name
Zach Itozu
Consultant phone
+813 6832 8683
Job Reference
JN-082023-6154062
Company Type
Foreign Multinational

Diversity & Inclusion at Michael Page

We don't just accept difference - we celebrate it. We encourage applicants from all backgrounds to apply for this role and are committed to building inclusive, diverse workplaces where everyone can thrive. If you require any support or reasonable adjustments during the recruitment process, please let us know.