Related skills
regulatory affairs regulatory submissions clinical development ich-gcp eu regulatoryπ Description
- Provides regulatory guidance across the clinical development lifecycle
- Coordinates and reviews submissions to Regulatory Authorities and Ethics Committees
- Represents Global Regulatory Affairs at project team meetings
- Maintains regulatory plans and intelligence tools; updates leadership
π― Requirements
- Bachelor's degree or equivalent in science/healthcare
- 5+ years of regulatory affairs experience
- Strong knowledge of EU and US regulatory processes
- Experience with regulatory submissions (CTA/IND), and meetings
- ICH-GCP guidance and high-quality documentation practices
- Excellent written and verbal English; MS Office proficiency
π Benefits
- Discretionary annual bonus
- Health insurance
- Retirement savings benefits
- Life insurance
- Parental leave
- Paid time off
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