※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
[Salary] 6〜9 million JPY ※Experiences and skills will be considered
This position is accountable to assist regulatory activities and deliverables in Japan. This responsibility includes: Drive the regulatory activities in company, develop and implement Japan regulatory strategy proactively in global development
- Manage projects and daily tasks in Japan so that the department objectives are implemented.
- Ensure continued constructive dialogue with PMDA and other regulatory bodies
1. Assist RA members and project team with the responsible for some specific area in the following tasks
- Responding to and negotiating with the regulatory authorities from development through approval
- Preparation of PMDA consultation strategy/briefing documents, and query response
- Build and maintain good relationship with PMDA to increase company's effective-ness in its intention
- Preparation of CTD (including obtaining company approval for them) to ensure that documents are prepared in a timely manner, to a high quality, and in accordance with regulatory strategy.
- Query response preparation and other necessary tasks during review of HA
- Transfer regulatory knowledge to Marketing and Medical
2. Ensure appropriate update of registration files of marketed products in collaboration with GRA, Japan QA and other relevant departments
3. Establish, maintain and ensure adherence to RA procedures for the department (SOP, eDOC, eRIMS). Ensure compliance with all applicable guideline, regulations and laws
4. Other relevant tasks in RA (Regulatory Intelligence, Information disclosure, etc.)
- Master's or Bachelor's degree within science, e.g. pharmaceutics, biomedicine, chemistry or related field
- At least 3 years of experience in Regulatory Affairs in Pharma industry
- Knowledge of the drug development process and maintenance of marketed products
- Excellent communication skills both in English and Japanese
- Excellent ability to learn fast with challenging spirit
- Excellent ability to cope with ambiguous situation and to build self
- Creating Innovation
- Structuring Tasks
- Drive for Results
- Building Relationships
- Showing Resilience
- A driving personality, with willingness to lead/drive something to get things done
- Willing to work collaboratively, good team player
- Be a strong communicator, verbally and in writing
- Be customer focused
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Seniority Level: Mid-Senior level
Job Function: Health Care Provider