-Leads oversight of compliance with tracking, updating and implementation of regulatory requirements
-Manages the consolidation of commitments to HAs and oversight of compliance with their execution
-Facilitates Key MAH responsible meetings, supporting Soseki.
-Facilitates regulatory inspection for GQP and GVP, including necessary adjustment with TMG.
-Works to maintain compliance to documents / letters submitted to HO, including Product Approval letters, Explanation letters, response to inquiries, etc.
-Manages supporting activities to meet Approval Conditions,
-Reports to Soseki and provide recommendations for improvement when necessary.
<Experience and Skills>
-Proven track record in interpreting, monitoring and recommending application of regulations pertinent to the overall company compliance, quality and safety
-In-depth knowledge of regulatory environment and strong curiosity and business acumen on future regulatory trends for the pharmaceutical industry in Japan.
-Excellent analytical skills and ability to identify non-compliance to requirements and develop / oversee action plans for corrective actions
-Excellent interpersonal and communication skills in Japanese with both internal and external stakeholders, with the ability to effectively communicate on and embed to MAH license compliance assurance activities across the organization.
-Successful project and or program management experience, demonstrating strong planning and organizational skills
-Successful track record in team leadership and people management
-Minimum graduate degree and 8-year experience in the industry or undergraduate degree followed by 12-year experience in the industry
<Qualification - Preferable>
-Japanese Pharmacist License
-Successful experience in managing organizational changes e.g. building new teams
-Comfortable communicating in business English
Janssen Pharmaceutical K.K. (7195)ジョブ
Regulatory ComplianceRequisition ID