Development RA Manager

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...