Job Description

Be part of one of the top global biopharma companies in the industry. Take lead in post-marketing RA activities for the business.

Description

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Lead Regulatory Submissions: Oversee the preparation and submission of regulatory dossiers (CTD/eCTD) in collaboration with global and Japanese teams, ensuring compliance with local requirements.
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Coordinate with Stakeholders: Work closely with global and Japan regulatory affairs teams to manage dossier content, including the Japanese CTD Table of Contents.
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Manage Regulatory Systems: Implement and maintain global and Japan-specific regulatory systems with a focus on technical functionality and compliance.
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Vendor and Workspace Oversight: Direct outsourcing vendors for eCTD development and manage the CTD/eCTD workspace for dossier preparation.
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Ensure Compliance and Continuous Improvement: Provide updates on Japanese eCTD requirements to global teams and lead initiatives to maintain and enhance regulatory IT system quality.

Profile

* University degree in scientific or related field
* High fluency in English and Japanese (non-native level speakers will not be selected)
* Experience in regulatory submissions utilising IT systems such as Veeva
* Submission dossier preparation experience

Job Offer

* Competitive salaries and benefits
* Great work life balance
* Hybrid working style
* Amazing career progression in RA
* Work with industry leaders who are solving various unmet medical needs

Page Group Japan is acting as an Employment Agency in relation to this vacancy.

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