About the Role
About the Role
Key Responsibilities
- Develop and execute regulatory strategies for investigational and development-stage products.
- Prepare, review, and submit regulatory documents to health authorities (e.g., INDs, CTAs, briefing packages).
- Collaborate with cross-functional teams including clinical development, medical affairs, CMC, and global regulatory teams.
- Monitor regulatory requirements and changes in guidelines across key markets (e.g., PMDA, FDA, EMA).
- Provide regulatory input during clinical trial planning, protocol development, and study execution.
- Support interactions with regulatory agencies, including meeting preparation and follow-up.
- Ensure documentation and submissions are accurate, timely, and compliant with applicable regulations.
- Contribute to risk assessments and mitigation strategies related to r...
Ready to Apply?
Submit your application today and take the next step in your career journey with Real Staffing.
Apply Now