
Global Regulatory Compliance Manager
1 day ago
Regulatory CMC Lead Specialist
This role leads and implements all global CMC submission activities for assigned projects/products. It involves formulating and leading global CMC regulatory strategy, maximizing business benefit balanced with regulatory compliance.
Responsibilities:
- Develop and implement global CMC regulatory strategies to ensure compliance and maximize business benefits.
- Lead and coordinate all global CMC submission activities, including planning, authoring, reviewing, coordination, and submission.
- Identify and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Author and review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends, and guidelines.
- Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
- Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate.
- Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals, and risk mitigation plans.
Requirements:
- Operations Management and Execution experience.
- Cross-cultural experience.
- Project Management skills.
- Collaborating across boundaries.
Benefits:
- Delivers reliable, timely, and accurate information/communication about project-specific issues within own department and to key stakeholders.
- Provides high-quality regulatory evaluation and strategic advice on time (change control, etc.); regulatory compliance met in all compliance systems.
- Maintains collaborative partnerships with stakeholders.
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