Role: Senior Manager, Regulatory Strategy
Responsibilities:
- Lead U.S. and global regulatory strategies for innovative neuroscience therapies.
- Drive regulatory planning from early development through post-approval phases.
- Ensure compliance with FDA/ICH requirements and align strategies with company objectives.
- Guide preparation and submission of INDs, NDAs, and sNDAs.
- Lead agency interactions and assess regulatory risks.
- Influence portfolio decisions based on regulatory insights.
Qualifications and Skills:
- Strong understanding of regulatory requirements and submission processes.
- Experience in managing cross-functional collaborations.
- Excellent strategic thinking and communication skills.
- Patient-focused approach with a collaborative mindset.