AI Success™

Job Description

企業概要

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok

求人内容

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 Development, Project Management, Commercial) to deliver regulatory input throughout product life-cycle management.
Lead and implement regulatory strategies, considering both global and local requirements.
Interact with PMDA/MHLW and internal stakeholders to facilitate communications, resolve issues, and ensure regulatory compliance.
Monitor and interpret regulatory changes/practices relevant to assigned products/areas; communicate updates to relevant teams.
Support the development and maintenance of regulatory SOPs and best practices, if applicable.
Contribute to departmental or cross-functional initiatives to promote operational efficiency and regulatory excellence, if applicable.

資æ ¼

Essential Skills & Abilities:

Regulatory Knowledge: Solid understanding of Japanâs regulatory requirements and procedures.
Teamwork: Effective collaboration in multi-functional teams; openness to learning and knowledge sharing.
Project Management: Ability to handle multiple projects, prioritize tasks, and consistently meet deadlines and quality standards.
Problem-Solving: Analytical and proactive approach to identifying and resolving regulatory and operational issues.
Communication: Verbal and written communication skills in Japanese and business level in English, with proven ability to collaborate cross-functionally and manage diverse stakeholders.
Compliance Orientation: Exceptional attention to detail with a robust understanding of regulatory frameworks and industry requirements.

Education/Experience Required:

Bachelorâs or Masterâs degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Public Health, Clinical Development, Engineering).
Experience in regulatory affairs within the pharmaceutical or healthcare industry is required, including preparation or review of regulatory submissions.
Direct project experience (new drug development and life-cycle management) strongly preferred.
Experience managing communications with regulatory authorities is valued.

ãã®ä»ã®æå ±

About AbbVie

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.

Learn more about us at www.abbvie.com and review our community guidelines at https://www.abbvie.com/social-media-community-guidelines.html.

Industry

Chemicals & Materials

Company Size

10,000+ employees

Headquarters

North Chicago, Illinois

Year Founded

Unknown

Website

abbvie.com

Social Media

Manager, RA TA Group, Regulatory Affairs(Oncology)