CMC RA Senior Manager/AD China submissions

Position Overview

• Location Type: China (Onsite)
• Job Type: Full Time
• Salary: Not specified

Description: At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. This is a client dedicated role; To further strengthen our CMC team, we are looking for an Associate Director CMC China Dossier Development. 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:

• Leads the preparation of CMC documentation for China clinical and commercial dossiers, in development in close collaboration with external and internal stakeholders.
• Leads CDE consultation meetings and interactions from CMC perspective and leads preparation of scientific briefing documents and regulatory response documents with support of the global CMC team.
• Leads 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.
• Ensures submission packages are complete and compliant with applicable regulatory and country specific requirements.
• Oversees activities in relation to local QC testing, with support of the global CMC analytical team.
• Coordinates activities with external and internal partners ensuring that deliverables are executed with the right priorities and to the required standards.
• Provides strategic input into CMC development activities.
• Tracks 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.

Requirements:

• Master’s degree or PhD in relevant field (biotechnology, pharmaceutical sciences, bio-engineering).
• Experience in CMC development and regulatory affairs in China.
• Expertise in large molecule CMC development (preferred).
• Strong regulatory writing skills.