May 26, 2022

Job Description

Communicate with global development team, BD&L partners and SKK’s relevant group/division during new
product development (small molecule generics and biosimilars), prepare PMDA consultation materials for
CMC-related matters, prepare dossiers (especially CMC-related parts) and submit them to PMDA. And
prepare documents for CMC-related raw data/GMP compliance review, prepare and review answers against
PMDA’s inquiries, interact with authority on CMC-related matters during product development and dossier
review, acquire approvals as scheduled.

Your Responsibilities:
Work with global development team (BD&L partners), other SKK development groups (Regulatory & External
Affairs Group, Non-Clinical & Clinical Group), Commercial Product Strategy Div., Legal & Compliance Office,
Commercial Excellence & Product Strategy Dep, GQP Quality Assurance Group, Commercial Operation QA
Control Group to make adequate development and regulatory strategies.
 Monitor new regulation, industry trend and originator’s product information.
 Communicate with global development team and BD&L partners to obtain necessary information for regulatory
evaluation and to provide them with inputs on Japanese regulatory/market requirement. Evaluate BD&L
development candidates.
 Prepare PMDA consultation materials for CMC-related matters.
 Prepare dossiers (especially CMC-related parts) with reliability and integrity based upon documents prepared
by global development team, submit them to PMDA, prepare documents for CMC-related raw data/GMP
compliance review, prepare and review answers against authority’s inquiries for dossier review and CMC
related raw data/GMP compliance review, and acquire approval as scheduled.
 Interact with authority on CMC-related matters, such as PMDA consultation, Dossier review, Raw data/GMP
compliance review.
 Support launch preparation
 Maintain marketing authorization approval of products (Partial change applications, Minor change notifications)

 新しい薬事規制、業界の動向、および先発品会社の製品情報を注視する。
 グローバルの開発チーム、導⼊品のパートナー会社及びサンド内の関連部⾨と協働し、薬事評価に必要な情報を⼊⼿し、また、⽇本の薬事規制及び市場の要求事項をフィードバックする。また、他社からの導⼊品⽬の評価を⾏う。
 CMC関連事項に関するPMDA相談資料を作成する。
 グローバル開発チームが作成した資料に基づいて、信頼性と整合性を備えた申請資料(特にCMC関連パート)を作成し、PMDAに提出する。また、CMC関連の⽣データ及びGMPの適合性調査に関する資料の作成、PMDAの照会事項に対する回答の作成を⾏い、予定どおりに承認を取得する。
 CMC関連の事項について、簡易相談・対⾯助⾔、申請資料の確認、⽣データ・GMP適合性調査等についてPMDAと協議する。
 新製品の発売準備をサポートする。
 品⽬の製造販売承認を維持管理する

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you will bring to the role:
Experience in pharmaceutical development (analysis, manufacturing), CMC management, Regulatory (interaction with authority, CMC dossier preparation),
Ability to handle multiple projects simultaneously
Science / Technical degree at University / College (Pharmacists feasible)

Language:Business level in English and Japanese

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Sandoz!
Commercial OPS SIR SZ
Research & Development
Full Time
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Senior Associate, Biosimilar Development , Sandoz

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