Regulatory Operation Director at Global Leading Pharma

Take lead in regulatory submission activities for the business to get product approval. Be involved in publishing and archiving activities to ensure best practices.
Client Details
* One of the top global patient-centric pharmaceutical companies in the industry
* Delivering cutting-edge therapies and products to patients with unmet medical needs
* Specializing in rare disease and orphan drug products with several blockbuster therapies out on the global market
* Global working environment with extensive communication with global stakeholders
* Hybrid style working style
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.