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gcp regulatory affairs clinical trials regulatory submissions ms office 365📋 Description
- Provides regulatory guidance throughout the clinical development life cycle
- Coordinate and review submissions to Regulatory Authorities including CTA/IND, annual reports, amendments, and meetings
- Develops and reviews documents for regulatory submissions to Authorities and Ethics Committees
- Represents Global Regulatory Affairs at project team meetings with internal and external customers
- Leads regional or global regulatory efforts and coordinates Regulatory Affairs Specialists
- Maintains project plans, trackers and regulatory intelligence tools for assigned responsibilities
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