CMC China Dossier Development Associate Director, Contract

Location Singapore
Discipline Life Sciences
Job Reference BBBH147258_1737539257
Salary Negotiable
Consultant Name Kang Abelene Marianne Mrs Rozario Abelene Marianne
Consultant Email [email protected]
Consultant Contact No. 6551 5320
EA License No. 02C3423
Consultant Registration No. R2089914


CMC China Dossier Development Associate Director, Contract

The candidate will be responsible for leading the preparation of CMC documentation for China submissions for our large molecule therapeutic drug candidates throughout their clinical development towards marketing approval and their post-approval stage. In this role you will have a front seat in the development and life-cycle management of novel therapeutics and to weigh into CMC development strategies.

Key Accountabilities and Responsibilities:
Contributes to the CMC development and life-cycle management of clinical and commercial stage programs in close collaboration with the CMC team members by:

  • Lead the preparation of CMC documentation for China clinical and commercial dossiers, in development in close collaboration with external and internal stakeholders;
  • Lead CDE consultation meetings and interactions from CMC perspective and lead preparation of scientific briefing documents and regulatory response documents with support of the global CMC team;
  • Lead life cycle management of China dossiers relating CMC according to regional needs;
  • Responsible for assessing regulatory impact of CMC change controls on China dossiers, and strategizing variation filing;
  • Ensure submission packages are complete and compliant with applicable regulatory and country specific requirements;
  • Oversee activities in relation to local QC testing, with support of the global CMC analytical team;
  • Coordinating activities with external and internal partners ensuring that deliverables are executed with the right priorities and to the required standards;
  • Providing strategic input into CMC development activities;
  • Tracking execution of regulatory commitments.


Qualifications:

  • Master degree or PhD in biotechnology, pharmaceutical sciences or bio-engineering, with relevant expertise in CMC development and CMC regulatory affairs in China;
  • Science oriented, experience with large molecules is a plus;
  • Excellent regulatory writing skills coupled with comprehensive knowledge of pharmacopoeial requirements, ICH guidelines, China, FDA and EMA/CHMP regulations and guidelines, and other international regulatory requirements;
  • Team player; able to build effective relationships with internal and external stakeholders;
  • Well organized and able to handle multiple assignments in parallel;
  • Eye for detail and quality conscious attitude;
  • Hands-on, self-initiative, Proactive - can do mentality;

Kang Abelene Marianne Mrs Rozario Abelene Marianne

EA License No.: 02C3423 | Personnel Reg No.: R2089914

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