Related skills
gcp project management regulatory affairs ms office 365 regulatory strategy📋 Description
- Provides regulatory guidance throughout the clinical development life cycle.
- Coordinate and submit regulatory applications to authorities and ethics committees.
- Develops/reviews regulatory documents to ensure compliance.
- Represents Global Regulatory Affairs in project team meetings.
- Leads regional or global regulatory projects as needed.
- Oversees Regulatory Affairs Specialists to meet submission targets.
🎯 Requirements
- Bachelor's degree or equivalent in science/healthcare.
- 5+ years regulatory experience (7+ for Senior Manager) with CRO background.
- Experience leading regulatory submissions (EU/US IND/CTA, etc.).
- Knowledge of ICH GCP and drug development process.
- Proficient in MS Office 365 and regulatory document management.
- Fluent in English; strong written and verbal communication.
🎁 Benefits
- Remote work flexibility.
- Opportunity to work on oncology/rare disease programs.
- Equal Opportunity Employer.
- Collaborative, cross-functional team and development focus.
- Support for professional growth and ongoing training.
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