job posting · smartrecruiters
AbbVie Inc.: RA TA Group, Regulatory Affairs
Observed on the employer’s careers system, last checked 2026-09-10.
- Employer
- AbbVie Inc.
- Location
- Tokyo
- Category
- Human Resources
- Posted
- 2026-09-10
- Careers system
- smartrecruiters
- Observed
- 2026-09-10
Role description
Verbatim from the employer’s posting, rendered as plain text.
Summary of Job Description: Manager, Regulatory Affairs (RA) Therapeutic Area (TA) Group, Regulatory Affairs Japan, is accountable for executing regulatory activities within assigned projects or therapeutic areas, acting as a core member of project teams. This role ensures timely and high-quality regulatory deliverables, supports regulatory strategy, and maintains compliance with applicable regulations and company policies. The Manager proactively collaborates with internal and external stakeholders and contributes to the continuous improvement of regulatory processes. Major Responsibilities: Execute regulatory affairs activities for assigned projects, including preparation and submission of regulatory documents (e.g., New Drug Applications, PMDA consultations, Clinical Trial Notifications, package inserts) to PMDA/MHLW. Collaborate with cross-functional project teams (e.g., Clinical…
Provenance
3743990015163355