Global CMC Regulatory Professional
17 hours ago
This role involves preparing and publishing regulatory documentation for health authorities. The individual will interact with these authorities on chemistry, manufacturing, and control (CMC) related questions to support the launch of new or existing products.
Main Responsibilities:
- Create a comprehensive global CMC regulatory strategy that balances innovation with compliance requirements.
- Oversee the planning, authorization, review, coordination, and submission of global CMC documents for assigned projects/products.
- Develop high-quality CMC documentation for health authority submissions by applying agreed-upon global regulatory strategies, current trends, and guidelines.
- E nsure the technical consistency and regulatory compliance of submitted documents, meeting agreed timelines and e-publishing requirements.
- Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned for major submissions and escalate as necessary.
- Initiate and lead interactions with health authorities, setting objectives, preparing briefing books, coordinating rehearsals, and risk mitigation plans.
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