锦鲤求职岗位描述
岗位职责
• Support the RA CMC Lead on project teams and provide regulatory expertise and input on cross-functional team recommendations to facilitate successful product development globally.
• Support RA CMC Lead and CMC teams to develop global submission plans that comply with local regulatory requirements and commitments.
• Manage the preparation of regulatory dossiers for submission to global Health Authorities throughout the product lifecycle.
• When appropriate support meetings with Health Authorities under supervision. Develop and reach consensus on regulatory CMC strategy for Health Authority information request responses, as needed.
• Provide regulatory assessments of CMC changes to project teams and refine regulatory strategies as needed.
岗位要求
• A minimum of a Bachelor of Science in biological, pharmaceutical, chemical, or engineering sciences.
• Experience in biologics is required.
• Understanding of CMC submission documents that support clinical trials, marketing, and lifecycle management .
• Strong attention to detail with high-level verbal and written communication skills is required; effectively communicates cross-functionally.
• Ability to quickly absorb new technical and strategic information and have the flexibility to adapt accordingly.