Director, Regulatory Affairs

📋 Description

• Provide strategic regulatory advice across product lifecycle, incl. NDA/BLA submissions.
• Prepare and oversee regulatory docs: US INDs, NDA/BLA modules, Orphan Drug filings, Fast Track.
• Lead regulatory development projects with cross-functional teams.
• Act as client-facing regulatory advisor and main contact for regulatory matters.
• Engage with health authorities (FDA) for meetings and submissions.
• Collaborate to align regulatory strategy with development goals.

🎯 Requirements

• Bachelor in science or related field; advanced degree preferred.
• 10+ years in CRO or pharma with 5+ years leading programs.
• ICH GCP knowledge and international regulatory guidelines.
• Strong clinical trials knowledge from Phase I–IV.
• Experience with CRO-pharma interactions and regulatory strategy.
• Excellent regulatory writing and verbal skills; leadership abilities.

🎁 Benefits

• US hiring range $195,000–$223,000; bonuses; regional adjustments as needed.
• Final compensation based on skills and location.
• Fully remote; flexible time off; paid holidays.
• Medical, tuition reimbursement, retirement plans (location-based).
• Opportunity to work with international team on therapies.
• Inclusive, collaborative workplace culture.