Director, Regulatory Affairs CMC

📋 Description

• Provide strategic CMC leadership across biologics for late-stage development.
• Lead global CMC regulatory submissions (INDs, CTAs, BLAs, MAAs).
• Serve as primary interface for CMC Health Authority interactions.
• Coordinate regional submissions and responses to Health Authority queries.
• Collaborate with Technical Operations, Quality, and Supply Chain on process and quality alignment.
• Identify CMC regulatory risks and drive proactive mitigation with cross-functional teams.

🎯 Requirements

• 10+ years in Regulatory Affairs with CMC in biotech/pharma.
• Proven Phase 3 global development submissions (IND/CTA/BLA/MAA).
• Leadership in Health Authority meetings, briefing packs, and negotiations.
• Deep know-how in biologics manufacturing, analytics, and quality systems.
• Strong knowledge of FDA, EMA, MHRA, PMDA, ICH; pragmatic application.
• Familiarity with eCTD and regulatory info systems (Veeva).

🎁 Benefits

• Committed to equal employment opportunity.
• Hybrid onsite schedule: minimum 2-3 days per week.
• No unsolicited resumes from recruitment agencies.
• Competitive benefits package.