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gcp regulatory affairs clinical trials regulatory submissions ms office 365📋 Description
- Provides regulatory guidance throughout the clinical development life cycle
- Compile, coordinate and review regulatory submissions/meetings
- Develops and reviews regulatory documents for submissions to authorities and ethics
- Serve as Global Regulatory Affairs representative at project teams
- Lead projects for the region or globally when required
- Oversee and coordinate Regulatory Affairs Specialists to meet submission targets
🎯 Requirements
- Bachelor's degree or equivalent in a scientific/healthcare field
- 5 years regulatory experience (Manager) or 7 years (Senior Manager)
- Computer literacy with MS Office/Office 365
- Fluent in English
- Regulatory affairs experience in CROs and leading submissions
- Knowledge of EU/US regulatory processes and ICH GCP
🎁 Benefits
- Equal opportunity employer with an inclusive culture
- Opportunity to impact cancer therapies in oncology/rare disease
- Global project exposure with occasional travel
- Professional development and regulatory leadership input
- Supportive team environment and recognition of contributions
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