Job Description:
We are seeking an experienced Regulatory Affairs Professional to join our team. In this role, you will be responsible for ensuring global regulatory compliance with external requirements and internal quality procedures across all markets.
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Key Roles and Responsibilities:
This includes developing and implementing global regulatory strategies, preparing and reviewing high-quality CMC submissions, leading CMC activities for assigned projects, representing CMC on cross-functional project teams, maintaining up-to-date regulatory documentation and systems, managing commitments and ensuring submission compliance.