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Director of Regulatory Affairs
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$210,000 - $235,000 a year
Full-time
- The Director of CMC Regulatory Affairs will be responsible for developing, leading and executing CMC regulatory strategies and activities for the organization, including the preparation and filing of regulatory CMC submissions.
- This position is a hands-on role, providing both strategic and operational activities to support regulatory needs for rare disease studies.
- The Director of Regulatory CMC will report to the global Head of Regulatory.
- Lead a team of stakeholders to develop/implement effective CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risk
- Ensure oversight of multiple programmes and drive regulatory CMC strategy successfully
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