About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
求人内容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 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.
資格
Essential Skills & Abilities:
- Regulatory Knowledge: Solid understanding of Japan’s 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:
- Bachelor’s or Master’s 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.
アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。
Skills Required
- Solid understanding of Japan regulatory requirements and procedures (PMDA/MHLW submissions)
- Experience in regulatory affairs within pharmaceutical or healthcare industry, including preparation or review of regulatory submissions
- Bachelor's or Master's degree in Life Sciences, Regulatory Affairs, Public Health, Clinical Development, Engineering, or related field
- Ability to handle multiple projects, prioritize tasks, and meet deadlines and quality standards (project management)
- Verbal and written communication skills in Japanese and business-level English
- Analytical and proactive problem-solving skills; compliance orientation and attention to detail
- Direct project experience in new drug development and life-cycle management
- Experience managing communications with regulatory authorities
AbbVie Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.
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Retirement Support — Retirement programs are portrayed as a standout, with a dollar‑for‑dollar 401(k) match up to 6% and an additional annual company contribution based on age and service. Feedback suggests this materially boosts perceived total compensation for many U.S. employees.
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Parental & Family Support — Paid parental and caregiver leave are emphasized, including up to 12 weeks of fully paid parental leave for all parents and 4 weeks of paid caregiver leave in the U.S. Feedback suggests these policies are a meaningful differentiator for employees balancing family needs.
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Leave & Time Off Breadth — Time off is described as extensive, with tiered vacation that scales with tenure, 17 company holidays, and two paid volunteer days in the U.S. Feedback suggests the breadth of leave contributes notably to overall benefits satisfaction.
AbbVie Insights
What We Do
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.
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