Senior Associate of Regulatory Strategy & CMC Group

Oct 18, 2021

Job Description

As part of Sandoz Japan development team, this role is critical in future Sandoz Japan growth by contributing development activity support and regulatory activities for small molecule generic products and biosimilars (in-house global products and in-licensed products) from early development phase to getting the MA approval.

Your responsibilities:
• Work with global development team (and BD&L partners), other SKK development & Medical divisions (Regulatory & External Affairs Group, Non-Clinical & Clinical Group, Medical office, Pharmacovigilance Operation), Legal & Compliance Office, Commercial Product Strategy Division, Onco Marketing Group (BU, Hospital & Bio), Marketing Group (BU, Retail), GQP Quality Assurance Group and External Supply Operation Department to make adequate development and regulatory strategies for small molecule generic product and biosimilar.
• Monitor new regulation, industry trend and originator’s product information.
• Communicate closely with global development team and BD&L partners during product development to fully support product development for Japan scope by providing them with “review comments for obtained development-related documents” and “necessary inputs on Japanese regulatory/market requirement”, etc. Also, evaluate BD&L development candidates during due diligence phase.
• Arrange all necessary activities of PMDA consultation for regulatory strategy, clinical strategy and quality strategy, etc.
• Prepare dossiers mainly including (but not limited to) CMC-related parts with reliability and integrity based upon documents prepared by global development team, compile all of the dossiers, submit them to authority, 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 for PMDA consultation, Dossier review, Raw data/GMP compliance review as regulatory representative.
• Support launch preparation (analytical method transfer, etc) and regulatory maintenance (CMC evaluation and dossier preparation, etc).

What you’ll bring to the role:
• Leadership in development team to enhance product development for Japan scope
• Knowledge and experience on finding out problems/risk, taking proactive action and/or making risk mitigation plan to boost success probability for Japan scope development
• Effective communication to establish confidential relationship with global development team and authority and to succeed in difficult negotiation.
• High inspiration/motivation on timely submission/approval/launch

You’ll receive:
• Opportunity of various and wide involvement in development activities for small molecule generic product and biosimilar
• Opportunity of working closely with global development team
• Opportunity of close interaction with authorities

Minimum Requirements

• Science / Technical degree at University / College (Pharmacists feasible)
• Business level in English
• Experience in pharmaceutical development (analysis, manufacturing), CMC management, Regulatory (interaction with authority, CMC dossier preparation), or GQP/GMP
• Ability to handle multiple projects simultaneously
• eCTD experience preferable
Commercial OPS SIR SZ
Research & Development
Full Time
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Senior Associate of Regulatory Strategy & CMC Group

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