Related skills
ms office gcp english regulatory affairs regulatory submissions📋 Description
- Provide regulatory strategy for clinical trials
- Coordinate CTA/IND submissions and agency meetings
- Prepare submissions for authorities and ethics committees
- Lead regulatory activities for regional/global programs
- Maintain project plans, trackers and regulatory intelligence
- Mentor Regulatory Affairs staff and train teams
🎯 Requirements
- Bachelor's degree or equivalent in science/healthcare
- 5+ years regulatory experience (Manager) or 7+ years (Senior Manager)
- Fluent in English; MS Office (Office 365)
- Experience in CROs and leading clinical submissions
- Strong regulatory strategy and project leadership
- Willingness to travel domestically and internationally
🎁 Benefits
- Remote work with global teams
- Equal opportunity employer
- Professional development and growth
- Supportive, collaborative work culture
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