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.

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 with a high diversity in terms CMC technologies and development complexity.

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.

Incorporate country specific requirements into project planning, align with global CMC team 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.

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, Additional documents in M3, PPQ requirements, Development/manufacture forms etc.)

Contract testing. Registration testing (Documents, samples requirement & readiness, challenges/issues etc.)

ChP

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Requirements

Education/Experience

• PhD in Sciences or Engineer degree (Biology, Biotechnology, Bioengineering, Chemistry, Pharmaceutics, Analytical etc.) with experience in CMC Development.
• Past experience in project management would be a plus.
• Experience in managing international and/or multi-cultural teams

Technical skills & Competencies

• Knowledge in CMC development, R&D and Industrial interfaces
• Skills in Project Management
• Well-rounded knowledge in flows/sequence and contents of CMC activities and regulatory requirements along product development and life cycle management
• English oral and written communication skills
• Able to lead transversely a multidisciplinary & multicultural team.
• Excellent negotiation skills

Behavioral Competencies

• Put the interest of the organization ahead of own and those of his/her team
• Take action and don't wait to be told what to do
• Good networking skills in cross-cultural environment
• High willingness and ability to become acquainted with new fields (e.g. Drug Development, Device Development, Industrialization, Launch Readiness)
• Ability to cooperate transversally with many partners from different part and level of the organization
• Strategic thinking
• Self-motivated
• Output oriented with pragmatic approach to new process implementation and problem solving
• High ability in change management