Take lead in regulatory submission activities for the business to get product approval. Be involved in publishing and archiving activities to ensure best practices.
Description
* Lead in Regulatory Operations in submissions and being informed of up to date regulatory information to manage tracking systems
* Be the main point of contact in electronic submissions, including new data requirements tracking regulatory data for RIM system
* Create eCTD documents and electronic JNDA Data to the PMDA and other health authorities
* Manage any regulatory dossiers to align with Regulatory Operations
* Provide expertise in global SOPs in Regulatory Operations to relevant teams
Profile
* University degree in scientific or related fields
* High fluency in English and Japanese (Non-native level speakers will not be selected)
* Extensive experience in RA or Regulatory Operations in the pharmaceutical industry
* Knowledge of CTD/eCTD requirements to submit to health authorities
* Exposure in compiling/publishing to prepare for overseas submissions (ex. US/EU)
Job Offer
* Competitive salaries and benefits (potential RSUs)
* Great work life balance
* Global working environment
* Amazing career development in regulatory area
* Work with key leaders who are solving unmet medical needs
Page Group Japan is acting as an Employment Agency in relation to this vacancy.