・Applicants must have permission to work in Japan
・Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)
☑外資系企業 ☑英語力が必要 ☑リモートワーク可能 ☑フレックス勤務
PURPOSE OF POSITION
Timely complete the registration plan to meet the requirements of JP business development in conjunction with marketing forecasts and plans. Ensure that the product meets the regulatory requirements of JP health authority.
Provide RA feasibility plan for the company's business development plan, interpret and follow up the regulations, and make timely adjustments. Ensure good communication with relevant teams to support business objectives.
- Communication with health authorities
- Support business strategy through the Registration regulatory assessment
- Submission, handle authorities inquires ,maintaining licenses, registrations, approvals, and FMA including :
- partial change applications,
- minor change notifications ,
- new product applications and
- foreign site registrations and maintain the registrations,
- according to reasonable time line
- Prepare and maintain project plans and timelines of approvals and planned submissions, update global RA roadmap in time.
- Establish the registration regulatory strategies of QMS application. Prepare the application documents for QMS and the documents for paper based QMS audit, submit and handle authorities' inquiries
- Prepare the documents for foreign site registrations and maintain the registrations
2. MKT material RA approval
- Review and approve marketing communication materials from registration regulatory aspect of the marketed products.
3. Coordinate and teamwork
- Provide regulatory information to and interact with Global/APAC RA and work towards common goals and shared submission planning
- Coordinate with marketing, local, regional and global RA team to make product registration plan and ensure updates to the shared submission planning file is communicated to Global RA
- Represent the company on external regulatory groups and networks for continuous learning, influencing and best practice
- Leading, MKT and other business related departments held local RA review meetings to clarify product registration plans, phased progress and required support.
- Regulatory submission strategies and regulatory submissions in agreement with manager, marketing and GM of Japan
- Approve marketing communication materials from regulatory aspect
- University degree, preferably in life science at least at a Bachelor of Sciences.
- At least 6-8 years of work experiences of RA responsible.
- Knowledge of Japanese regulatory-related laws and regulations including recent law amendments
- Business level written and spoken English skills
- Strong communication, planning and negotiation skills.
Seniority Level: Mid-Senior level
Job Function: Science, Other