Regulatory Affairs Manager

Job Number: 1368

External Description:

Key Accountabilities:

Develop and execute regulatory affairs (RA) activities from the development to the life cycle management, with collaborative with global and Japan stakeholders. Regulatory Affairs Manager will focus on some of the following activities in Regulatory Affairs Group 1 or Group 2:

• Lead RA-related Health Authority (HA) interactions.   e.g., PMDA Consultation, Clinical Trial Notification (CTN), etc.

• Lead New Drug Application (NDA) and supplementary NDA (sNDA) such as indication expansion, new formulation, etc.

  • Lead preparation of the Japan NDA activities and HA’s review for approval.

  • Prepare the Japan-CTD regulatory parts such as Approval Application Form, Module 1, etc.

• Manage Partial Change Application (PCA)/Minor Change Notification (MCN) [Change Control Process/Post-marketing activities] with collaborative with CMC team.

• Lead electronic Japanese Package Inserts (J-PI), respond to query, and join artwork activities. Review promotion materials.

• Manage Outsourcing vendors as needed.

• Represent RA for the SOPs/WI updates and improvement tasks.

Candidate Profile:

Education and Preferable work experiences:

• Experiences in R&D such as Regulatory Affairs.

• Experiences of Collaborating with cross-functional team and global member.

Competencies and skills:

• Language: Japanese- native level. English: Able to communicate with global members as J-RA representative.

• Stakeholder management: Communication/coordination, leadership/ownership skills, strategic consideration and project/risk management skills (e.g., To Clarify regulatory risks and plan/execute minimization/mitigation).

Job Number: 1368

Community / Marketing Title: Regulatory Affairs Manager

Location_formattedLocationLong: Tokyo, Tokyo JP