Associate Director – Technical Regulatory Affairs

Key Responsibilities

• Design and lead Technical Regulatory Affairs strategy for assigned projects.
• Prepare regulatory quality documents (CTD Modules 2 & 3, IMPD, IND).
• Prepare briefing books for Health Authority meetings.
• Coordinate with CMC, DRA, QPs, CMOs and regulatory partners.
• Lead cross-functional discussions and documentation challenges.
• Evaluate regulatory impact of product/process changes.
• Ensure global regulatory and GMP compliance.
• Manage documentation storage and track global submissions.

Must Haves

• Master’s degree or higher in a scientific field.
• 7+ years experience in technical/CMC regulatory affairs.
• Strong knowledge of ICH, GMP and global regulatory procedures.
• Understanding of drug substance/product development and manufacturing.
• Excellent communication, leadership and organizational skills.
• Fluent English; additiona...