Regulatory Affairs Manager or Associate, Sasayama

326783BR
Sep 05, 2021
Japan

Job Description

Supports effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP.

Your key responsibilities
/Regulatory Affairs operations (business license application, renewal, import notification, export notification, various change notification, etc.)
/Ensuring compliance with manufacturing (including packaging), storage, testing, and other approved items related to the Sasayama Plant
/Appropriate responses to GMP compliance inspections at the Sasayama Plant

薬事上の業態管理業務(業許可申請・更新・輸入届・輸出届・各種変更届等)
篠山工場に関連する製造(包装含む)・保管・試験等の承認事項に対するコンプライアンス確保
篠山工場に対するGMP適合性調査への適正な対応

Minimum Requirements

What you’ll bring to the role:
/ Regulatory Affairs Law and related laws, regulations, and notifications
/Skills to conduct FD submissions
/Supports the implementation of Quality Systems (incl. documentation management)
/Acquire cGMP/QMS knowledge
/Knowledge of GMP required to perform regulatory affairs such as change control, document control, validation, buildings and facilities in Sasayama Plant
/Need recrements Novartis Health ,reinsurance and environments
/Ability to understand the contents of approval

Bachelor's degree or equivalent
Language: Business level English (TOEIC 730 level), Native level Japanese

1. 薬事法及びその関連法規・通知の知識
2. FD申請を実施するためのスキル
3. 当局対応/窓口を遂行するための適正なコミュニケーション能力及び柔軟性のある交渉能力
4. cGMP/QMS知識の習得
5. 篠山工場における変更管理、文書管理、バリデーション、構造設備等、薬事業務を遂行するに当たり必要なGMPの知識
6. Novartis HSE要求事項に対する知識
7. 承認内容の理解力

750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons
Novartis Technical Operations
NTO QUALITY
Japan
Sasayama
Quality
Full Time
Regular
No
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326783BR

Regulatory Affairs Manager or Associate, Sasayama

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