Job Description
Job Title: CMC Project Manager
Solid Line Manager: Local Head of CMC Project Excellence
Job Purpose
The CMC Project Manager is a key contributor of the CMC Project Excellence department to provide a world class performance of Sanofi CMC Project Management.
The CMC Project Manager enables the most efficient transversal collaboration within and outside of CMC, fostering and aligning efficient ways of working, providing the relevant expertise and adding value by creating synergies across CMC entities, platforms, cross functions through fundamental excellence in Project Management expertise to achieve successful and fast submission and approval in China.
The role is covering the following CMC scope:
Key Accountabilities
Cross-functionally manages local CMC activities in R&D specifically related to the submission and approvals of new products in China reflecting the CMC strategy of each project, drives CMC project strategic discussions to accelerate time to submit/approval in China. Covers a portfolio of projects from early-stage development up to approval (~5 projects) with a high diversity in terms CMC technologies and development complexity.
Designs and implements standards and business processes for CMC Project Management in China in collaboration with local R&D, M&S as well as CMC global team, acts as China ambassador towards global CMC team organization to enhance understanding and management of China specificities. Deploy CMC best practices, proactively contribute to the evolution of CMC best practices and experience sharing within CMC Dev and across R&D、M&S functions, drive China CMC operational excellence.
Set up project CMC China workstream, organize and leads cross-functional CMC meetings for China submissions/approvals. Identifies and manages risks related to China-specific CMC activities, working transversally with local and global project actors. Foresee challenges & hurdles for China submission/approval. Contribute to project documents & governance meetings preparation.
Incorporate country specific requirements into project planning, align with global CMC project leaders on project strategy, plan, timelines, resources, costs, risk management and mitigation plan. Build end-to-end CMC plans for China covering all CMC related activities at developmental stages, IND/NDA/BLA submissions and regulatory approvals and ensure integration of activities across functions including R&D CMC platforms, RA, Reg-CMC, Clinical/Commercial Supply Chain and production and testing sites (including CMOs etc.). Drive the execution of CMC activities in accordance with project planning, manage proactively country specific topics/risks, detect deviations from project plan, assess impact on deliverables and adjust project plan timely. Develops scenarios and provides recommendations for optimization.
Supporting project outsourcing activities in China CDMOs.
May interact with Health Authority upon request of Regulatory Affairs in collaboration with RA RegCMC by delegation of the CMC Project Leader.
CMC China specific topics refer below but not limited to the list:
China IND/NDA/BLA submission package requirement for CMC (Dossier M1/ M2/M3, specific administrative documents including JS/JX, DMF etc; Additional documents in M3, PPQ requirements, Development/manufacture forms etc.)
Contract testing. Registration testing (Documents, samples preparation, challenges/issues etc.)
ChP/DMF topics
…
Support Business Development Licensing-in projects. Lead (or co-lead with global) CMC/manufacturing Due Diligence teams to assess Business Development opportunities. Prepare CMC project plan including cost and resources for potential licensing products and associated risk assessment and mitigations. Coordinate contract negotiation of deals and term sheets for CMC, M&S and Quality related topics. Implementation of signed inlicensing deals.
Support transversal initiatives contributing to simplification & harmonization. Support Operational Excellence initiatives (SMS, 5S, etc)
Requirements
Education/Experience
Technical skills & Competencies
Behavioral Competencies
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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