
CMC Regulatory Specialist
2 days ago
Job Summary:
-Regulatory professionals who specialize in chemistry, manufacturing, and control (CMC) activities prepare and publish regulatory documentation for submissions to health authorities. This involves interacting with these authorities on CMC-related questions to support the launch of new products or existing ones.Key Responsibilities:
- Develop a comprehensive global CMC regulatory strategy that balances innovation with compliance.
- Lead the planning, authoring, reviewing, coordination, and submission of global CMC documents for assigned projects/products.
- Prepare high-quality CMC documentation for health authority submissions by applying agreed-upon global regulatory strategies, current trends, and guidelines.
- Ensure the technical congruency 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.
Requirements:
- Experience working with drug products is essential.
- Operational management and execution are crucial.
- Collaboration across teams is vital.
- Project management skills are necessary.
- Negotiation, project management, and regulatory compliance are key.
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