药政注册经理（CMC）(J19716)

职位描述

• 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.

任职要求

• 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.