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東京都の臨床開発・薬事の求人231件応募資格・募集要項・仕事内容を見る
Senior Regulatory Affairs Professional APAC
- 給与
- 記載なし
- 勤務地
- 東京都
- 休日
- 記載なし
- 雇用形態
- 記載なし
どんな仕事かAIによる生成
The Senior RA Professional is part of the Global Regulatory Affairs organization in the AP Region and provides regional regulatory strategy and support for assigned products. The role works with local affiliates, Global Regulatory Teams and regional functions on registrations, lifecycle management, submissions, Health Authority interactions and ongoing compliance.
この求人に応募
応募資格
必須
- Bachelor’s degree or equivalent in Pharmacy, Life Sciences, or a health-related discipline.
- 2 – 8 years of overall relevant pharmaceutical industry experience, preferably including regulatory experience.
- Excellent verbal and written English communication skills, including the ability to communicate with senior management.
歓迎
- Hands-on experience registering pharmaceutical products in AP countries and familiarity with AP regulatory systems and requirements.
- Experience preparing Health Authority submission documents (Chemistry & Manufacturing and/or Registration dossiers) and in HA interactions.
- Understanding of drug development and/or marketed products, including awareness of AP pricing, reimbursement and supply chain impacts on registration.
- Demonstrated ability to manage multiple projects, with strong organizational skills.
- Proficiency in Mandarin or other Asian languages.
- Cultural sensitivity and ability to thrive in a multicultural, matrix environment as a proactive, adaptable team player.
募集要項最終確認 11/5
- 職種
- 臨床開発・薬事
- 雇用形態
- 記載なし
- 給与
- 記載なし
- 勤務地
- Chiyoda, Tokyo, Japan
- 働き方
- 記載なし
- 勤務時間
- Flexible hours required to accommodate early morning/evening meetings across time zones.
- 経験年数
- 2年以上
- 学歴
- 大学卒業以上
- 掲載日
- 2026/11/05 21:50（1日前）
- 最終確認
- 2026/11/05 21:50（1日前）
仕事内容
POSITION OVERVIEW
- The Senior RA Professional is a member of the Global Regulatory Affairs organization. The position resides in the AP Region and is responsible for working with local regulatory affairs departments, AP regional cross-functional teams, Global Regulatory Teams and other global functions to define and implement the regional strategy for assigned products.
- The position, under supervision, is accountable for leading and providing region or country strategic input into the global regulatory strategy and identifying regional requirements to optimize registration and lifecycle management of marketed products, taking into consideration current and proposed changes in regulatory requirements and standards.
- This position provides regional affiliates with timely responses to Health Authority enquiries and gives general regulatory support to all affiliates in the region for the pharmaceutical sector business.
CORE RESPONSIBILITY
- As a member of the AP regional regulatory team, you will provide strategic regional regulatory input for assigned products across Asia-Pacific, supporting timely registrations, lifecycle management and ongoing compliance. You will partner with local operating companies, Global Regulatory Teams and regional functions to translate global strategy into region-specific regulatory plans and deliverables.
ROLE DESCRIPTION
- Advise the Global Regulatory Team (GRT) and Compound Development Team (CDT) on regional regulatory requirements, guidelines and issues impacting product strategy; participate as a standing GRT member where applicable.
- Provide regional input to expedite new indications and line extensions, and guide local affiliates on strategies to accelerate submissions and approvals.
- Serve as point of contact for local operating companies and support preparation for Health Authority (HA) interactions, including timing and strategy for HA meetings.
- Provide input to submission planning and timelines, including lifecycle submissions (labeling changes, renewals and safety reports), and review critical submission documents.
- Participate in Rapid Response Teams to ensure timely, appropriate responses to HA questions.
- Contribute to regional implementation of Core Data Sheets; under supervision, review labeling revisions and support labeling negotiations with HAs.
- Track submission and approval milestones and regional post-approval commitments, ensuring follow-up and ongoing compliance.
- Provide AP evaluation in licensing activities, monitor regional regulatory changes and update global teams on their impact.
- Contribute to department processes and support VP, Regulatory Affairs AP initiatives as requested.
ADDITIONAL INFORMATION
- Operates independently with limited managerial oversight, setting longer-term priorities in consultation with supervisor.
- Minimal regional business travel (1–2 times per year); occasional international travel may be required.
この求人は、ジョンソン・エンド・ジョンソン株式会社の採用ページの内容をAIが読み取って整理したものです。応募の前に採用ページの原文を確かめてください。データの集め方企業サイト
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応募はジョンソン・エンド・ジョンソン株式会社の採用ページで受け付けています。このページは採用ページの掲載内容をもとに構成しているため、最新の応募条件は募集元でご確認ください。
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