Sanofi

RegulatoryManager

Tokyo, Japan FULL TIME
The Brief

“Regulatory Manager at Sanofi. Skills: Regulatory CMC, Japan regulations, Submission dossiers. Develop innovative Japan regulatory CMC strategies. Manage post-marketed CMC change controls”

What You'll Achieve.

Achieving the goals and improving performance and productivity of the RA-J and RCMC

Industry & Context.

Problems you'll solve

Resolving strategic technical and regulatory issues; Risk assessments; Mitigated risks; Optimal solutions

What They're Looking For.

Must Have

Knowledge of Japan & global regulations/guidelines, Knowledge of key Health Authority/Industry thinking and trends, Capable of resolving strategic technical and regulatory issues, Knowledge of Japan regulatory dossier requirements, Business level of English fluency (oral and written)

Nice to Have

Technical pharmaceutical CMC experience (QC laboratory, manufacturing, etc.), Experience working for a Regulatory Health Authority, Potential to be able to mentor and train staff

What You'll Do.

Develop innovative Japan regulatory CMC strategies

Manage post-marketed CMC change controls

Conduct regulatory impact assessment

Prepare dossier package for submissions

Manage CMC writing and preparation

Contribute to global RCMC topic

Monitor Health Authority regulations

How You'll Work.

Team & Collaboration

Create collaborative working relationships with Global Regulatory CMC&D Focal Points; Collaborate with Japan Regulatory Group; Collaborate with Technical and Quality Groups; Collaborate with Manufacturing and Supply (M&S); Collaborate with Regulatory Health Authorities; Collaborate with CMC teams; Collaborate with Japan post-marketed regulatory group; Collaborate with global/local M&S functions; Collaborate with Global regulatory CMC&D FP; Collaborate with Global CMC Dossier; Collaborate with M&S site SMEs; Collaborate with GRA Regulatory Operations

Communication Scope

Communicate effectively to internal and external audiences

Process & Methodology

Manage portfolio of development projects, Manage post-marketed products, Manage CMC activities, Manage HA meeting briefing documents, Manage post-marketed CMC change controls, Manage CMC responses, Manage CMC writing, preparation, review and approval, Manage regulatory inspection process

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