Director, Regulatory Affairs - Development Strategy

Responsibilities

• Lead regulatory due diligence assessments for external assets
• Critically assess completeness and adequacy of data packages, identifying gaps and risks
• Provide clear regulatory recommendations for business development decisions
• Contribute to global regulatory strategies for assigned programs
• Support preparation and submission of various regulatory documents
• Engage in health authority interactions and develop meeting strategy
• Monitor evolving regulatory landscape and propose practical mitigation strategies

Qualifications

• Bachelor's degree with 5+ years in Regulatory Affairs or related fields
• Hands-on experience in regulatory submissions in regions like U.S. and EU
• Experience in early-stage drug development from pre-IND to Phase 2
• Strong understanding of global regulatory frameworks
• Ability to critically assess scientific and clinical data in a regulatory context